APEX Spine System Surgical Technique - Zimmer Biomet€¦ · 4 APEX Spine System – Degenerative...

APEX Spine SystemSurgical Technique

2 APEX Spine System – Surgical Technique

APEX Spine SystemSurgical Technique

Description, Indications & Contraindications . . . . . . . . . . . . . . . . . . 3

Degenerative Surgical Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Fixed Length Cross Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Multi-Span Cross Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Deformity Surgical Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Hook Correction Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Pedicle Screw Correction Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Vertebral Column Derotation Surgical Technique. . . . . . . . . . . . . . . 28

Derotator Triangulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

En-Bloc Spinal Derotation (Multiple Apical Levels) . . . . . . . . . . . . . . . . . . . . . . . 32

Segmental Spinal Derotation (Individual Vertebral Level). . . . . . . . . . . . . . . . . . 36

Revision/Removal Surgical Technique . . . . . . . . . . . . . . . . . . . . . . . 40

Tray Layouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Warnings, Precautions, & Possible Adverse Effects . . . . . . . . . . . . 54

APEX Spine System – Surgical Technique 3

Description, Indications & Contraindications

DESCRIPTIONThe APEX Spine System consists of longitudinal rods, pedicle screws (monoaxial, polyaxial and bolt-type), cannulated pedicle screws (monoaxial and polyaxial), hooks, lateral connectors and transverse (cross) connectors.

The APEX Spine System components are available in titanium alloy conforming to ASTM F136 specifications. Rods are also available in Cobalt Chromium alloy conforming to ASTM F1537 specifications.

INDICATIONSThe APEX Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AIM Spine MIS instrumentation*, the APEX Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients. Levels of fixation are for the thoracic, lumbar and sacral spine.

CONTRAINDICATIONSDisease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.

Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.

Severe osteoporosis is a relative contraindication because it may prevent

adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system.

Any condition not described in the Indications for Use.

Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure. See also the WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES section of this insert.

* Note: SpineCraft’s AIM MIS System is distributed directly by SpineCraft, not by Zimmer Spine.

4 APEX Spine System – Degenerative Surgical Technique

Instruments

Starter AwlSC-6000-45

Step 1Determine the pedicle canal entry site. (Fig.1)

Step 2Prepare the pedicle canal, using preferred instrumentation. (Fig.2)

Fig. 1 � Fig. 2 �

X

X

X

X

X

X

Pedicle Preparation Degenerative Surgical Technique

APEX Spine System – Degenerative Surgical Technique 5

Instruments

Fig. 3 �

Step 3Insert the Pedicle Probe into the established entry site, gently pressing through the pedicle canal. (Fig.3)

Step 4Screw insertion should follow the angle of the pedicle canal. (Fig.4)

Step 5Insert a Straight or Curved Sounding Probe and palpate the hole’s inner surface to verify pedicle wall integrity. (Fig.5) Clamp a hemostat to the Sounding Probe to aid in determining hole depth.

NOTE: Guide Pins may be placed to identify appropriate screw trajectory via a lateral x-ray/fluoroscopy view.

Fig. 4 � Fig. 5 �

Sounding Probe SC-6000-43 Curved SC-6000-44 Straight SC-6000-44-H Straight (Hard Steel) SC-6000-44-1-H Small, Straight (Hard Steel) SC-6000-44-1-SH Small, Straight (Super Hard)

Pedicle ProbeSC-6000-49 LumbarSC-6000-48 Thoracic


Instruments

Step 6Polyaxial Screwdrivers are used in conjunction with the Ratcheting T-Handle. Polyaxial screws are inserted using a Polyaxial Screwdriver.

To load a polyaxial screw, insert the boss of the Polyaxial Screwdriver into the U-shaped slot of the screw tulip. Simultaneously rotate the polyaxial screw shank to position the driver tip into the shank’s hexalobe socket. Slide the driver sleeve down and turn it clockwise to engage the tulip thread, then tighten. Once fully engaged, the screw can be inserted into the vertebral body.

NOTE: Ensure that the driver is fully engaged with the screw prior to inserting. The shaft of the screw will not toggle when the driver is fully engaged and the two lines, marked on the sleeve and on the internal driver shaft, will be aligned.

Implant the polyaxial screw into the desired pedicle and advance to a depth where full angulation of the polyaxial head is maintained. (Fig.6)

NOTE: Further advancement limits the angulation of the polyaxial screw.

Repeat the process until all polyaxial screws are placed.

NOTE: At any time during screw loading, the “Lock” button on the driver can be pressed down (Fig.7) to prevent disassembly of the driver sleeve with the screw tulip during screw insertion. When disassembling, make sure that the “Unlock” button of the driver on the opposite side is pressed down (Fig.7 inset).

Fig. 6 � Fig. 7 �

Polyaxial Screw Insertion

Ratcheting T-HandleSC-6000-03

Polyaxial Screwdriver with Tulip-lock SC-6000-89-PS Regular SC-6000-89-PLG Large SC-6000-89-DR Dedicated Reduction


Instruments

Step 7Monoaxial Screwdrivers are used in conjunction with the Ratcheting T-Handle.

Monoaxial screws are inserted using a Monoaxial Screwdriver.

To load a monoaxial screw, insert the boss of the Monoaxial Screwdriver into the U-shaped slot of the screw tulip. Slide the driver sleeve down and turn it clockwise to engage the tulip thread, then tighten. Once fully engaged, the screw can be inserted into the vertebral body.

Step 8Once screws have been placed, the appropriate rod length is determined. The rod should extend approximately 5mm beyond the distal edge of the superior screw tulip and the most proximal edge of the inferior screw tulip. (Fig.8)

6.0mm and 5.5mm diameter rods are available in the following lengths: 30, 40, 45, 50, 60, 70, 80 and 90.

NOTE: All rods except the 45mm length are available as both straight and pre-lordosed options. The 45mm length is available as pre-lordosed only.

Step 9Place the rod provisionally into each screw and determine the amount of contouring required to achieve the desired sagittal profile.

Contour the rods as needed using the French Rod Bender. (Fig.9) The bend radius is variable. By pulling out and rotating the central button of the Rod Bender, a small, medium, or large radius may be selected.

Fig. 8 � Fig. 9 �

Monoaxial Screw Insertion Rod Selection Rod Bending

Monoaxial ScrewdriverSC-6000-85

Monoaxial Screwdriver Tightening KeySC-6000-90-S

Rod Holder ForcepsSC-6000-11

French Rod BenderSC-6000-16-S


Instruments

Fig. 10 �

A contoured rod should fit into the bottom of each screw tulip. (Fig.10)

Step 10When screw insertion and rod bending is complete, the rod is placed in the screws’ tulips U-shape slots using the Rod Holder Forceps or the Straight Rod Clamp. The Long or Short Forceps Rocker and/or the Pistol Grip or Axial Persuader may be used to seat the rod while inserting set screws with the T30 Starter Driver. (Fig.11)

NOTE: The optional Axial Persuader T-Handle (SC-6000-01-AT) can be used when additional mechanical advantage is needed during reduction step.

Step 11Use the T30 Starter Driver to introduce the set screw into the screw’s tulip. Two set screws can be picked at a time by lowering each end of the T30 Starter Driver onto the set screw and pushing to snap into place.

Turn the T30 Starter Driver clockwise to start the set screw. (Fig.12)

The set screw starts easily when properly aligned. If incorrectly aligned, it will exhibit noticeable resistance during the initial threading. If this occurs, back the set screw completely off the screw and check that it is properly seated.

Repeat the process until all set screws are inserted.

Fig. 11 � Fig. 12 �

Rod Placement Set Screw Insertion

Rod Holder ForcepsSC-6000-11

Straight Rod ClampSC-6000-12

Persuader SC-6000-01-A Axial SC-6000-01 Pistol Grip

Axial Persuader T-HandleSC-6000-01-AT

T30 Starter DriverSC-6000-30-2

Forceps Rocker SC-6000-05 Long SC-6000-06 Short


Instruments

Fig. 13 �

Step 12When the set screws have been inserted, the Straight Rod Clamp may be used to rotate the contoured rod into lordosis. (Fig.13) While the rod is held in place with the Clamp, the set screw in the superior position is tightened using the Torque-Limiting T-Handle. The remaining set screws are left loose to allow for compression and distraction.

NOTE: The Torque-Limiting T-Handle 9.5 Nm (SC-6000-02) is for use with all set screws using a T30 Hexalobe Driver.

Step 13Provisionally tighten the set screw on one side of the segment being translated, while leaving the set screw on the contralateral side loose.

Perform compression (Fig.14) or distraction (Fig.15) against the provisionally tightened assembly.

After achieving the desired amount of correction, perform final tightening of the set screw.

Fig. 14 � Fig. 15 �

Rod Rotation Compression/Distraction

Torque-Limiting T-Handle 9.5NmSC-6000-02

T30 Hexalobe Driver SC-6000-30-M

Large Compressor SC-6000-42

Large Distractor SC-6000-41

Anti-Torque SC-6000-98 Regular SC-6000-98-LG Large


Instruments

Fig. 16 �

Step 14When all implants are securely in place and the rod fully seated, final tightening is performed. Set screws are tightened using the T30 Hexalobe Driver, the 9.5 Nm Torque-Limiting T-Handle, and the Anti-Torque. (Fig.16)


Step 15Once final tightening of the set screws is completed, it is mandatory that transverse connectors be placed to provide rotational stability to the construct. (Fig.17) Final tightening of the cross connector should be done using 8.5 Nm Torque-Limiting T-Handle and the Cannulated Cross Connector Anti-Torque as described in the following section.

NOTE: The Torque-Limiting T-Handle 8.5 Nm (SC-6000-02-C) is for use with all set screws using a T20 Hexalobe Driver.

A framed construct resists rotational forces. Ideally, cross connectors should be placed close to the construct extremities. (Fig.18) Two cross connector systems are available: the Fixed Length system and the Multi-Span system.

Fig. 17 �� Fig. 18 �

Final Set Screw Tightening Cross Connectors





Instruments

Fig. 19 �

FIXED LENGTH CROSS CONNECTORThe Fixed Length Cross Connector is low profile and ideal for use in the thoracic region.

MULTI-SPAN CROSS CONNECTORThe Multi-Span Cross Connector is very flexible and highly adjustable, and is available in various sizes. The first two sizes are appropriate for the thoracic region, and the last three sizes are appropriate for the lumbar region. (Fig.19)

The Multi-Span Cross Connector adjusts around 3 axes. (Fig.20) The arm slides in and out to increase or decrease the span (A), it rotates around its own axis (B), and the arm can rotate in the coronal plane (C). This allows the connector to be maneuvered into place and to adjust any rod-to-rod length and orientation.

Fig. 20 � Fig. 21 �

A

B

C

Cross Connector Types

Fixed Length Cross ConnectorsEstimate the Span Between the Rods

Cross Connector Measuring CardSC-6000-47

Step 15 Option 1aPlace the semi-circular notch of the Cross Connector Measuring Card on one of the rods and match the distance of the span using the pre-marked lengths on the card. Use the side that says “Fixed Length Connectors.” (Fig.21)


Instruments

Fig. 22 �

Step 15 Option 1bAttach the chosen cross connector to the Cross Connector Holder Forceps (optional, as illustrated above). Position the Cross Connector onto to the rods (A). Tighten the set screws with the 8.5 Nm Torque-Limiting Handle and the T20 Hexalobe Driver (B). (Fig.22)


Step 15 Option 2aUse the side of the Measuring Card labeled “Multi-Span Connectors.” Place the semi-circular notch on one of the rods and estimate the distance of the span using the ruled portion of the card. (Fig.23)

Step 15 Option 2bAttach the chosen Multi-Span Cross Connector to the Cross Connector Holder Forceps (optional, as illustrated above). Place the hooked ends of the cross connector onto the rods and tighten the yellow set screws on the ends with the 8.5 Nm Torque-Limiting Handle and the T20 Hexalobe Driver. (Fig.24)


Fig. 23 � Fig. 24 �

Place the Cross Connector

Multi-Span Cross ConnectorsEstimate the Span Between the Rods Place the Cross Connector

Cross Connector Measuring CardSC-6000-47

Cross Connector Holder ForcepsSC-6000-10

Torque-Limiting T-Handle 8.5NmSC-6000-02-C

T20 Hexalobe Driver SC-6000-20-MC


Instruments

Fig. 25 �

Step 15 Option 2cThe Cross Connector Anti-Torque slides onto the central screw of the cross connector as illustrated. Align the Anti-Torque slot labeled “Screw” over the upper arm of the cross connector and slide it down over the central screw (A). Then rotate the Anti-Torque counter-clockwise to secure it on the upper arm (B). (Fig.25)

Step 15 Option 2dHold the Anti-Torque with one hand and tighten the center screw fully with the 8.5 Nm Torque-Limiting Handle and the T20 Hexalobe Driver. (Fig.26)


Fig. 26 �

Position the Cross Connector Anti-Torque Tighten the Center Set Screw

Cross Connector Anti-TorqueSC-6000-99

Torque-Limiting T-Handle 8.5NmSC-6000-02-C


14 APEX Spine System – Deformity Surgical Technique

Hook Correction TechniqueHook Site Preparation/Options/Insertion

Hook Site Preparation/Options/PlacementDeformity

Surgical Technique

Fig. 27 ��

Surgical StrategyPreoperatively, any spinal surgery should be studied and a scheme of the construct defined. The following illustrations are examples of some typical hook constructs for a T4-L1 Adolescent Idiopathic Scoliosis. These schemes, which are strictly for illustrative purposes, are examples of how to treat these types of scoliosis. This figure above (Fig.27) shows a standard right thoracic curve (Lenke Type 1AN/King Type III) which can be instrumented with hooks from T4 to L1. This case can also be treated using a hybrid construct consisting of hooks and pedicle screws.

Step 1The APEX Spine System offers a number of top-loading hooks of different shapes and sizes. Any APEX Spine System Hook may be treated as a closed hook by simply placing the set screw into the hook prior to insertion of the rod. The surgeon must choose the appropriate hook based on the individual patient’s anatomy, deformity degree and type, method of correction chosen, and amount of compression/distraction that will be needed to provide proper and stable purchase of the implants. The Curved or Lateral Implant Holder Forceps can be used for hook insertion and can be combined with the Implant Pusher as illustrated. (Fig.28)

Step 1 Option 1PEDICLE HOOKThe pedicle hook may be used from T1 to T10. The hook blade is always cephalad (upgoing) and is in the infralaminar position. The facet capsule is divided, and a 2-3mm portion of the inferior facet process may be removed to facilitate insertion of the hook. (Figs.29, 30)

Fig. 28 �� Fig. 29 ��

Instruments

Implant Holder ForcepsSC-6000-08 Curved

SC-6000-09 Lateral

Implant Pusher Dual PurposeSC-6000-32

APEX Spine System – Deformity Surgical Technique 15

Fig. 30 ��

Once the pedicle has been clearly identified with the help of the Pedicle Elevator, the hook may be inserted. If needed, a mallet can be used to impact the pedicle hook. It is important that the pedicle hook is placed into the joint cavity and is not splitting the inferior articular process.

Step 1 Option 2TRANSVERSE PROCESS HOOKThis is generally a wide laminar hook and is typically used in a transverse process claw construct as a caudal (down-going) hook. (Fig.31) The Laminar Elevator or a transverse process elevator may be used to separate the ligamentous attachment between the undersurface of the transverse process and the posterior arch of the rib medial to the rib transverse joint. An Implant Holder is used to insert this hook.

Step 1 Option 3LAMINAR HOOKS:THORACIC SUPRALAMINAR HOOKThe direction of this hook is always caudal (down-going). A partial or total division of the spinous process directly above the vertebra to be instrumented (thoracic vertebra) may be performed. A division and/or partial removal of the ligamentum flavum and a small laminotomy are carried out on the superior lamina. The amount of bone removed from the lamina may vary depending on the size of the hook blade and throat angle chosen. The upper edge of the lamina below may be resected to ease the placement of this hook. The opening in the canal should not be too wide to avoid slippage of the hook body into the canal. The Laminar Elevator may be used to check the space between laminar and peridural structures. (Fig.32)

Fig. 31 �� Fig. 32 ��

Pedicle Elevator/FinderSC-6000-33

Laminar Elevator/FinderSC-6000-31

Implant Holder Forceps SC-6000-07 Straight SC-6000-08 Curved SC-6000-09 Lateral

Instruments


Step 1 Option 4LUMBAR INFRALAMINAR HOOKThis hook is always inserted in the cephalad direction (up-going) and is generally used at T10 or below. With this hook type, the ligamentum flavum is partially removed or separated from the inferior surface of the lamina using the Laminar Elevator, keeping the bone intact, if possible. An Implant Holder Forceps is used to insert the hook.

Step 2Once inserted, laminar hooks are not very stable prior to rod insertion. Therefore, it is recommended to remove them.

At this point in the surgery, bilateral partial facetectomies are carried out. (Fig.33) The intervening cartilage is denuded to allow exposure of the subchondral bone assisting in bone fusion. Decortication of the laminae, spinous processes, and transverse processes is done at this stage.

Step 3Once the hooks on the correction side of the deformity (concave in the thoracic area, convex in the lumbar area of the spine) are tested for fit and placement, a rod template may be used to determine the length and the curve. The correction rod is cut to the appropriate length (2 to 3cm longer than the overall hook-to-hook length). To achieve the correct sagittal plane contour, the rod is bent in small incremental steps using a French Rod Bender or In-Situ Coronal Rod Bender. (Fig.34) It is important to maintain a same plane orientation of the rod to prevent a spiral-type bend down the rod.

NOTE: In the case of a reducible scoliosis, the rod is bent according to the final postoperative planned correction to obtain a nice postopera-tive thoracic kyphosis and lumbar lordosis. In a case of stiff scoliosis, further in-situ contouring may be needed.

Fig. 33 �� Fig. 34 ��

Decortication Rod Contouring

Instruments


In-Situ Coronal Rod BendersSC-6000-14-LSC-6000-14-R

Laminar Elevator/FinderSC-6000-31

Implant Holder Forceps SC-6000-07 Straight SC-6000-08 Curved SC-6000-09 Lateral


Fig. 35 ��

Step 4The contoured rod is placed into the top-loading implants beginning from either the upper or lower part of the construct: there is no particular rule for rod insertion. (Fig.35) One can start with the implants in which the rod seems to best position and facilitate the continuation of the insertion. A rod holder may be used to assist in placing the rod. The Rod Pusher may be used to push the rod down in order to place a set screw and/or, due to its C-shape, to push the hook into its correct position.

Step 5

NOTE: There are several methods and instru-ments that may be used to facilitate rod reduction and to fully seat the rod into the saddle of the implants. Depending on the method and instruments used to reduce the rod, the set screws will be inserted with the T30 Starter Driver.

FORCEPS ROCKER METHODUse of the Forceps Rocker (Short or Long) is an effective method for reducing (or seating) the rod into the implant when only a slight height difference exists between the rod and the implant saddle. (Fig.36) To use the Forceps Rocker, the Forceps tips should be facing in the same direction as the hook blade. This angle will avoid dislodgment of the hook.

Lever the Forceps Rocker backwards over the rod to seat the rod into the saddle of the implant. The levering action allows the rod to be fully seated in the saddle of the implant. (Fig.37)

Fig. 36 �� Fig. 37 ��

Rod Insertion Rod Reduction


Rod Pusher SC-6000-34 Open SC-6000-35 “C”

Instruments

Forceps Rocker SC-6000-06 Short SC-6000-05 Long


Fig. 38 ��

Step 6

NOTE: At this point of the surgery part of the cor-rection has been achieved, mainly due to translation maneuvers used when inserting the rod. Further correction can be accomplished with rod rotation and/or in-situ bending, depending on the type and stiffness of the curve, and completed with compression/distraction maneuvers.

Once the contoured rod and all of the set screws have been placed, the rod is ready to be rotated into its final position. The rotation must be done slowly in order to prevent rapid neurologic changes and/or injury to the spinal cord. The rotation is done using two Rod Clamps. (Fig.38) It is important to monitor the interval hooks, which tend to back out during rod rotation. Several methods are proposed:

use of the “C” Rod Pusher, the placement of C-rings on the rod prior to rotation, placement of the Rod Clamps on the rod just below the hook to buttress it, or the use of the Lateral Implant Holder Forceps.

Once the rotation of the rod is complete and the position of the hooks is verified, the interval hooks’ set screws are provisionally tightened to prevent rod derotation. The hooks should be checked following all rotation maneuvers and the necessary adjustments made to ensure that proper placement is maintained. At this point, the rod should be fully seated into the saddle of all of the implants.

Step 7In-Situ Coronal Rod Benders may be used for correction and final adjustment of the rod in the coronal plane (Fig.39) and the In-Situ Sagittal Rod Benders may be used for correction of the rod in the sagittal plane. (Fig.40) The rod is bent in small incremental steps using the two bender tips positioned near each other on the rod.

Fig. 39 ��

Rod Rotation In-Situ Bending

Instruments


“C” Rod Pusher SC-6000-35

Lateral Implant Holder ForcepsSC-6000-09

In-Situ Sagittal Rod BendersSC-6000-94-LSC-6000-94-R





Fig. 40 ��

Step 8Once the rod is secured in the implants, distraction and/or compression are performed to place the hooks in their final position. The Compressor, Distractor, T30 Hexalobe Driver, and Rod Clamps are used to carry out these maneuvers. It is recommended to use the Rod Clamps as a stop for distraction maneuvers rather than the implant (Fig.41), with the exception of the inverted claw.

Compression maneuvers are most often carried out directly on two hooks. (Fig.42) Care should be taken to ensure that the foot of either instrument is placed against the implant body and not against the set screw. After these maneuvers are complete, the set screw is tightened.

Fig. 41 �� Fig. 42 ��

Compression/Distraction

Instruments








Fig. 43 ��

Step 9After completing the deformity correction and correction-rod seating, prepare the opposite side of the construct. Measure the length for the stabilizing rod, then cut. Using the French Rod Bender, contour the rod according to the curvature of the spine and the residual position of alignment from the correction rod. Place the contoured rod into the hooks and provisionally secure the rod with set screws. (Fig.43) Once the rod is secured to the implants, distraction and/or compression are performed to place the hooks in their final position.

NOTE: The spine may be decorticated to carry out the bone fusion and morselized cancellous bone placed along the decorticated spine, extending out over the transverse processes.

Step 10When all implants are securely in place and the rod fully seated, final tightening is performed. Set screws are tightened using the the T30 Hexalobe Driver, the 9.5 Nm Torque-Limiting T-Handle, and the Anti-Torque. (Fig.44)


Step 11Once final tightening of the set screws is completed, it is mandatory that transverse connectors be placed to provide rotational stability to the construct.

A framed construct resists rotational forces. Ideally, the cross connectors should be placed close to the construct extremities. (Fig.45) Two cross connector systems are available: the Fixed Length and the Multi-Span adjustable systems.

Final tightening of the cross connector should be done using 8.5 Nm Torque-Limiting T-Handle and the Cross Connector Anti-Torque. Refer to the Step 15 of the Degenerative Surgical Technique Section for specific instructions and instruments.

Following cross connector placement, wound closure is performed in the customary manner.

Fig. 44 �� Fig. 45 ��

Stabilization/Holding Rod Placement Final Tightening Cross Connector Placement/Closure

Instruments





Fig. 46 ��

Step 12Clean the facet joints and perform a partial inferior articular process osteotomy to enhance visualization and fusion. Remove 3mm to 5mm of the inferior facet and denude the articular cartilage on the superior facet, except for the lowest vertebra to be instrumented. This will allow for the intraoperative localization of the thoracic pedicle screw starting points. (Fig.46)

Anatomic starting points vary by the posterior elements that can be observed intra-operatively. These include the transverse process, the lateral portion of the pars interarticularis, and the base of the superior articular process. After a thorough exposure, use as much anatomic information as possible by starting with a neutral, nonrotated

vertebra. The lateral and posterior views shown above can be used as a guide for starting points and screw trajectory.

Use Monoaxial or Polyaxial Screws for the straightforward approach (Purple Pins). Use Polyaxial Screws only for the anatomic approach (Green Pins). (Fig.47)

Fig. 47 ��

Pedicle Screw Correction TechniqueThoracic Facetectomy

Thoracic Pedicle Screw Starting Points

Instruments

Thoracic Pedicle Screw Starting PointsLevel Cephalad-Caudal Starting Point Medial-Lateral Starting Point

T1 Midpoint TP Junction: TP-Lamina



T4 Junction: Proximal Third-Midpoint TP Junction: TP-Lamina

T5 Proximal Third TP Junction: TP-Lamina

T6 Junction: Proximal Edge Proximal Third TP Junction: TP-Lamina-Facet

T7 Proximal TP Midpoint Facet



T10 Junction: Proximal Edge-Proximal Third TP Junction: TP-Lamina-Facet

T11 Proximal Third TP Just medial to lateral pars


Fig. 48 ��

Step 13Create a 3mm deep posterior cortical breach with a high-speed burr. A pedicle “blush” may be visualized suggesting entrance into the cancellous bone at the base of the pedicle. Occasionally, when preparing small pedicles located at the apex of the curve, the blush will not be evident due to the limited intrapedicular cancellous bone. In this case, use the Thoracic Pedicle Probe to search in the burred cortical breach for the soft, funnel-shaped cancellous bone, which indicates the entrance to the pedicle. The tip should be pointed laterally to avoid perforation of the medial cortex. (Fig.48)

Step 14Grip the side of the handle to avoid applying too much ventral pressure. Insert the tip approximately 20mm to 25mm, and then remove the probe to reorient it so that the tip points medially. (Fig.49)

Step 15Carefully place the probe into the base of the prior hole and use the instrument markings to advance the probe to the desired depth. Rotate the probe 180° to ensure adequate room for the screw. (Fig.50)

Fig. 49 �� Fig. 50 ��

Pedicle Preparation

Instruments

Pedicle Probe SC-6000-48 Thoracic SC-6000-49 Lumbar


Fig. 51 ��

Step 16Check to ensure that only blood is coming out of the pedicle and that the bleeding is not excessive. Advance a Sounding Probe to the base (floor) of the hole to confirm five distinct bony borders: a floor and four walls (medial, lateral, superior, and inferior). (Fig.51) Give special care to the first 10 to 15mm of the track. Cortically breached pedicles may be salvageable. When necessary, place bone wax in the pedicle hole to limit bleeding, then reposition the probe with a more appropriate trajectory.

Step 17Next, undertap the pedicle by 0.75mm of the final screw diameter. (Fig.52) Palpate the tapped pedicle tract with a Sounding Probe (Fig.51). Clamp a hemostat to the exposed Sounding Probe and measure the length of the hole. Select the appropriate screw diameter and length by both preoperative measurement and intraoperative observation.

Step 18To load a polyaxial screw, insert the boss of the Polyaxial Screwdriver into the U-shaped slot of the screw tulip. Simultaneously rotate the polyaxial screw shank to position the driver tip into the shank’s hexalobe socket. Slide the driver sleeve down and turn it clockwise to engage the tulip thread, then tighten. Once fully engaged, the screw can be inserted into the vertebral body. (Fig.53)

Fig. 52 �� Fig. 53 ��

Screw Placement (Polyaxial Screws)

Sounding Probe SC-6000-43 Curved SC-6000-44 Straight SC-6000-44-H Straight (Hard Steel) SC-6000-44-1-H Small, Straight (Hard Steel) SC-6000-44-1-SH Small, Straight (Super Hard)

TapsSC-6000-71-40-NC Ø4.00mmSC-6000-71-47-NC Ø4.75mmSC-6000-71-55-NC Ø5.50mmSC-6000-71-62-NC Ø6.25mmSC-6000-71-70-NC Ø7.00mmSC-6000-71-77-NC Ø7.75mm


Polyaxial Screwdriver with Tulip-lock SC-6000-89-PS Regular SC-6000-89-PLG Large SC-6000-89-DR Dedicated Reduction

Instruments


Fig. 54 ��

NOTE: At any time during screw loading, the “Lock” button on the driver can be pressed down to prevent loosening of the driver sleeve with the screw tulip. (Fig.54)

When disassembling, make sure that the “Unlock” button of the driver on the opposite side is pressed down. (Fig.54 inset)

Step 19To load a monoaxial screw, insert the boss of the Monoaxial Screwdriver into the U-shaped slot of the screw tulip. Slide the sleeve down and turn it clockwise to engage the tulip thread, then tighten. Once fully engaged, the screw can be inserted into the vertebral body. (Fig.55)

Step 20Once correct screw placement has been verified radiographically, measure and contour rods in the sagittal and coronal planes. Clamping the rod with Rod Clamps at both ends helps prevent the rod from rotating during contouring. (Fig.56)

Fig. 55 �� Fig. 56 ��

Screw Placement (Monoaxial Screws) Rod Contouring/Placement

Instruments







Fig. 57 ��

Step 21ROCKER METHODUse of the Forceps Rocker is an effective method for reducing (or seating) the rod into the implant when only a slight height difference exists between the rod and the implant saddle. To use the Forceps Rocker, grasp the sides of the implant with the rocker cam above the rod (Fig.57) and then lever backwards over the rod. The levering action allows the rod to be fully seated into the saddle of the implant. The T30 Starter Driver is then used to introduce the set screw. (Fig.58)

NOTE: For non-hyperkyphotic deformities, place the rod on the concavity first. The contoured rod is placed into the previously placed screws. There are several methods and instruments that can facilitate fully seating the rod into the saddle of the implant.

Care should be taken with any of the following reduction methods. Improper instrument use may loosen implants or damage the residual facets and other bony anatomy. (Fig.54)

Step 22The set screws are kept loose (or only locked at one end), then the concave rod is slowly straightened with the In-Situ Coronal Rod Benders. Each straightening of the concave rod is performed over a pedicle screw. Several passes may be required in order for viscoelastic relaxation with subsequent curve correction to occur. (Fig.59)

Fig. 58 �� Fig. 59 ��

Rod Reduction Deformity Correction

Forceps Rocker SC-6000-06 Short SC-6000-05 Long


T30 Starter DriverSC-6000-30-2


Instruments


Fig. 60 ��

Step 23Tighten the apical set screws and perform the appropriate compression or distraction. Watch the screw/bone interface with all correction maneuvers. (Fig.60)


Step 24Following placement of the second rod and set screws (Fig.61), convex compressive forces are placed on the segments using the Large Compressor to horizontalize the lowest instrumented vertebra and mildly compress the convexity of the deformity (Fig.62). NMEP and/or SSEP monitoring are performed to detect slow progressions of neurologic deficits. Fixation is verified with A/P and lateral x-rays to confirm spinal correction and alignment.

Fig. 61 �� Fig. 62 ��

Instruments







Fig. 63 ��

Step 25The set screws are tightened using the T30 Hexalobe Driver, the 9.5 Nm Torque-Limiting T-Handle, and the Anti-Torque. This locks the rods into place. (Fig.63) The posterior elements are decorticated with a burr and the bone graft is placed.


Fixed Length or Multi-Span Cross Connectors should be placed at the proximal and distal ends of the construct. (Fig.64) Final tightening of the cross connector should be done using the 8.5 Nm Torque-limiting T-Handle and the Cross Connector Anti-Torque.

Refer to the Step 15 of the Degenerative Surgical Technique Section for specific instructions and instruments.


Fig. 64 ��

Final Tightening/Decortication/Placement of Cross Connector




Instruments

28 APEX Spine System – Vertebral Column Derotation Surgical Technique

Fig. 65 �� Fig. 66 �� Fig. 67 ��

Instruments

Vertebral Column Derotor Post(shown disassembled)SC-6000-801

Vertebral Column Derotation (VCD) using the APEX Spine System in Adolescent Idiopathic Scoliosis (Lenke 1 Curve)It is accepted that with the use of pedicle screws in Adolescent Idiopathic Scoliosis (AIS), significant coronal plane correction can be consistently obtained. True axial plane correction can now be achieved to address the rotational deformity of the spine, ribs and chest wall. The main goal of vertebral column derotation is to achieve rotational deformity correction, which may decrease the need for thoracoplasty. (Fig.65)

The VCD Posts engage the screws. (Fig.66) Prongs on the ends of the VCD Posts lock on the quad recesses of the APEX implants (see inset at arrow). (Fig.67)

Derotator TriangulationVertebral Column Derotation

Surgical Technique

APEX Spine System – Vertebral Column Derotation Surgical Technique 29

Fig. 68 �� Fig. 69 �� Fig. 70 ��

Vertebral Column Derotator Ring(part of SC-6000-801; shown disassembled)

Derotator Post Linking RodsSC-6000-805-100 100mmSC-6000-805-125 125mmSC-6000-805-150 150mmSC-6000-805-175 175mmSC-6000-805-200 200mm

Dual Purpose Derotator HandleSC-6000-808

Instruments

The outer sleeves of the VCD Posts slide down and a laser-etched arrow and line appear on the VCD Post when the outer sleeve is lowered sufficiently (Fig.68 inset), and the sleeve button will automatically lock into the lower shaft groove. (Fig.68)

The rings are secured to the tops of the VCD Posts. (Fig.69)

Insert a Linking Rod (different lengths available) through the top ring attachments and tighten the knobs. Use the Dual Purpose Derotator Handle to tighten the knob securely. (Fig.70)


Fig. 71 �� Fig. 72 �� Fig. 73 ��

Instruments


Correct placement of linking rod that allows for cannula access. (Fig.71)

Incorrect placement of linking rod. (Fig.72) The shaft end of a Dual Purpose Derotator Handle is inserted into the cannula of the VCD Post of the side without the rod in the pedicle screw tulips, allowing for rotation of the configuration. (Fig.73)


Fig. 74 �� Fig. 75 ��


Instruments

Step 1aON THE CONCAVE SIDEInsert APEX Monoaxial or Polyaxial Screws at every level. Consider also using APEX Polyaxial or Reduction Screws at the apex of the concavity, particularly for severe curves. Refer to the Deformtiy Surgical Technique Section for specific instructions.

ON THE CONVEX SIDEInsert APEX Polyaxial Screws into at least 3-4 convex pedicles at the apex, as well as the proximal and distal foundations. Refer to the Deformtiy Surgical Technique Section for specific instructions.

NOTE: Bilateral facetectomies should be carried out to allow proper positioning of the pedicle screws and interfacing of the screws with Vertebral Column Derotator Posts. (Fig.74)

Step 1bCONFIRM SCREW PLACEMENTConfirm placement of screws and check screws depth with fluoroscopy or plain x-rays prior to rod insertion.

Step 2Contour the rods with appropriate kyphosis to pull the apical vertebrae dorsally, and correct apical lordosis. (Fig.75)

NOTE: The amount of kyphosis given to the rod is also affected by the rod’s strength (material and diameter).

Screw Placement Contour the Rod


Fig. 76 � Fig. 77 � Fig. 78 �

Instruments

Step 3aTRANSLATION MANEUVERInsert the concave side rod proximally and distally. Tighten and lock the implant set screws proximally only, leaving the rod in the correct sagittal plane. Apical screws are translated to the rod segmentally by using reduction devices or reduction screws. Refer to the Deformity Surgical Technique Section for specific instructions.

The remaining set screws are inserted but not tightened to allow vertebral derotation later. (Fig.76)

Step 3bROD ROTATION MANEUVERPerform a rod rotation maneuver as in the classic CD Technique. In this case, the rod rotates from the midline scoliotic position laterally to the left. During the 90° rotation one must have control over the convex ribs by pushing down to avoid aggravating the rib prominence. (Fig.77)

Finally, proceed with one or both of the vertebral column derotation techniques explained in the following steps.

Step 4 Option 1aDEROTATOR ATTACHMENTAfter the concave rod is engaged in all anchors, attach the VCD Posts to apical screw heads on both concave and convex sides. (Fig.78) Refer to the Derotator Triangulation Section for assembly and linking instructions.

Rod EngagementEn-Bloc Spinal Derotation (Multiple Apical Levels)


Fig. 79 � Fig. 80 � Fig. 81 �

Derorator Interlink PlateSC-6000-802-P

Instruments

The Derotator pairs are connected with a Derotator Linking Rod by snapping the rings over the Post ends as shown in Fig.69.

The Derotator Interlink Clamps are attached to the individual posts. (Fig.79) Clamps are available in Standard, Medium, and Long lengths to accomodate Post relative positions.

The Derotator Interlink Plate is placed over the threaded clamp ends. (Fig.80)

The Derotator Interlink knobs are threaded onto the clamps to hold the Plate in place. (Fig.81)

Derotator Interlink ClampsSC-6000-802-SC StandardSC-6000-802-MC MediumSC-6000-802-LC Long


Fig. 82 � Fig. 83 � Fig. 84 �

Instruments

The knobs are tightened with a Dual Purpose Handle. (Fig.82) The other end of the Handle can be placed into a cannula of one of the posts for added control during the maneuver. (Fig.73)

Step 4 Option 1bPUSH ON THE CONVEX RIBSAn assistant pushes down on the convex ribs and the convex screws while the concave and convex screws are rotated in the direction that will reduce the rib prominence. (Clockwise in Figs.83, 84)

Step 4 Option 1cCONCAVE SCREW ROTATIONThis should be done simultaneously to distribute strain and to limit loading of the bone-screw interface. The rotation of the concave screws will help decrease the torsion and will lift the concavity out of the chest. (Figs.83, 84)

A rehearsal of this maneuver prior to rod insertion can be helpful to gain a sense of how much force is to be applied safely.



Fig. 85 � Fig. 86 � Fig. 87 �

Instruments

Step 4 Option 1dLIFTING THE CONCAVE SIDELifting the concave side out of the chest is effectively done with the VCD Posts locked on the quad recesses feature of APEX implants. This system provides 360° control of the anchor point without the need for additional instrumentation. (Fig.85) VCD Posts can be linked together and rotated in unison.

Step 4 Option 1eDEROTATOR ASSEMBLY REMOVALLoosen the knob at the top of each derotator post ring and remove the linking rods.

Press the side button to remove the ring from the top of each post. Loosen the interlink clamp knobs to remove the interlink assembly from the posts.

Press the removal button at the top of each derotator post to sleeve to slide it up and release the screw tulips. (Fig.86)

Step 4 Option 1f

TIGHTEN CONCAVE SIDETighten the set screws on the concave rod holding this position. (Fig.87) Refer to the Deformtiy Surgical Technique Section for specific instructions.



Regular Anti-TorqueSC-6000-98


Fig. 88 � Fig. 89 �

Instruments

Step 4 Option 1gTIGHTEN CONVEX SIDERemove the derotator posts. Implant the convex side rod and tighten the set screws on the convex side. (Fig.88) Refer to the Deformtiy Surgical Technique Section for specific instructions.

NOTE: Some surgeons believe that the VCD maneuver with both rods in place minimizes the loss of rotational correction that occurs from spine “spring back” when inserting and rotating one rod at a time. In this case, follow the same steps described above but with both rods already implanted.

Step 4 Option 2aSegmental Vertebral Column Derotation can be done as the sole derotation maneuver or in addition to the En-Bloc maneuver described in previous pages.

ROD IMPLANTATION Implant both rods and capture them with the set screws. Most set screws should be left loose since lengthening of the spine is expected at each level that will be segmentally derotated. Only the set screws in the distal neutral vertebra should be tightened. (e.g., L1 in Fig.89)

Step 4 Option 2bDISTAL DEROTATOR ATTACHMENTAttach two VCD Posts in the distal segment to lock the bottom neutral vertebra. (e.g., L1 in Fig.89) Then attach VCD Posts in the next proximal 1-2 vertebrae. The VCD Posts on the distal vertebra must be held by an assistant to provide counter-rotation force.

Segmental Spinal Derotation (Individual Vertebral Level)





Fig. 90 � Fig. 91 � Fig. 92 �

Instruments

Step 4 Option 2cDEROTATE INDIVIDUAL VERTEBRAEDerotate each proximal vertebral body to achieve a neutral position in reference to the neutral distal vertebra. (Figs.90 & 91) connect both VCD Posts of each vertebra with the Linking Rod to have a rigid triangular fixation on the vertebra and avoid screw cut out during derotation maneuver. After derotation of each segment, the set screws are tightened. Repeat this process, moving along towards the apex.

Step 4 Option 2dREPEAT DEROTATIONComplete neutral derotation may not be achieved at the apex relative to its torsion in the axial plane during the first pass. Repeating the derotation maneuvers at some levels can be helpful due to viscoelastic relaxation of the spine. Care must be taken not to loosen the bone-screw interface while performing the maneuver.

The VCD Posts or Derotation Tubes are effective in this step of Segmental Derotation.

Repeat the derotation for each segment, until all vertebral levels nearly match the neutrally rotated distal vertebra. (Fig.91)

Step 5During Segmental Spinal Derotation, segmental compression (convexity) and/or distraction (concavity) may be simultaneously applied using the Large Compressor and/or Distractor to effect maximal correction, just before the set screws are tightened.

Additional coronal correction can be achieved with the use of the In-Situ Coronal Rod Benders. (Fig.92) Refer to the Deformtiy Surgical Technique Section for specific instructions.

Compression/Distraction

Large CompressorSC-6000-42



Instruments

Step 6The set screws are tightened using the T30 Hexalobe Driver, the 9.5 Nm Torque-Limiting T-Handle, and the Anti-Torque; this locks the rods into place (Fig.93). (Refer to the Deformtiy Surgical Technique Section for specific instructions).


Step 7The posterior elements are decorticated with a burr (Fig.94) and the bone graft is placed. (Fig.95)

Decortication/Graft Placement


Regular Anti-TorqueSC-6000-98


Fig. 93 � Fig. 94 � Fig. 95 �


Instruments

Step 8Once final tightening of the set screws is completed, it is mandatory that cross connectors be placed to provide rotational stability to the construct. Final tightening of the cross connector should be done using 8.5 Nm Torque-Limiting T-Handle and the Cross Connector Anti-Torque. Ideally, the links should be placed close to the construct extremities. (Fig.96) (Refer to Step 15 of the Degenerative Surgical Technique Section for specific instructions).

Following cross connector placement, wound closure is performed in the customary manner.


Cross Connector Placement

Fig. 96 �

40 APEX Spine System – Revision/Removal Surgical Technique

Instruments

Cross Connector Anti-TorqueSC-6000-99

Step 1 Option 1FIXED CROSS CONNECTORTo remove the fixed cross connector, use the Ratcheting T-Handle and the T20 Hexalobe Driver. Turn the driver counter-clockwise to loosen the set screws.

Step 1 Option 2MULTI-SPAN CROSS CONNECTORTo remove or revise the Multi-Span Cross Connector, use the Cross Connector Anti-Torque, the T20 Hexalobe Driver and the Ratcheting T-Handle. Align the Anti-Torque slot labeled “Unscrew” over the upper arm of the cross connector and slide it down over the central screw. Then rotate the Anti-Torque clockwise to secure it on the upper arm. (Fig.91 inset)

Turn the handle counter-clockwise to loosen the central screw, then loosen the yellow set screws on the ends without the Anti-Torque. (Fig.91)

Cross-Connector RemovalRevision/Removal

Surgical Technique



APEX Spine System – Revision/Removal Surgical Technique 41

Instruments


T30 Hexalobe DriverSC-6000-30-M


Polyaxial Screwdriver with Tulip-lock SC-6000-89-PS Regular SC-6000-89-PLG Large SC-6000-89-DR Dedicated ReductionMonoaxial ScrewdriverSC-6000-85

Step 2To remove a set screw from a pedicle screw or a hook, attach the Ratcheting T-Handle to a T30 Hexalobe Driver and use with the Anti-Torque. Turn the handle counterclockwise to loosen and then remove the set screws completely. (Fig.92) Remove the rod.

Step 3The polyaxial screw tulips can be remobilized with the Universal Head Adjuster. After removing the set screw and the rod, fit the Universal Head Adjuster into the tulip. Toggle the tool to manipulate the head without rotation. (Fig.93)

Step 4Use the T20 Hexalobe Driver or the Polyaxial Screwdriver with the Ratcheting T-Handle to remove a polyaxial screw. Use the Universal Head Adjuster or the Monoaxial Screwdriver to remove a monoaxial screw. (Fig.94)

Pedicle Screw or Hook Set Screw Removal Tulip Remobilization Pedicle Screw Removal

Universal Head AdjusterSC-6000-75-U



APEX Spine System Degenerative Implant Set07.01957.402 5.5mm Degenerative Implant Set or 07.01959.402 6.0mm Degenerative Implant Set

Tray Layouts

Catalog Number Description Kit Quantity

SC-6000-310B-Z APEX Degenerative Implants Case 1

SC-RG-0002-1 APEX Spine System Implants IFU 1

SC-6000-310-6B Degenerative Polyaxial Screw Caddy 1

SC-PF6-5530 Poly Ti Pedicle Screw Ø5.50 x 30mm, Self-Tapping 6
























SC-6000-310-3B Regular and Large Set Screws Caddy 1

SS6-MPH95-T30 T30 Set Screw 9.5mm OD for Mono, Poly Screws and Hooks 40

S6-MPH95-T30L T30 Set Screw 11.0mm OD for Large Poly Screws 12

SC-6000-310-5B Ø6.25mm & Ø7mm Reduction Polyaxial Screw Caddy 1

SC-PR6-6240-F Poly Ti Pedicle Reduction Screw Ø6.25 x 40mm, Self-Tapping 2








SC-6000-310-4B Ø6mm Lordosed & Straight Rods Caddy 1

SC-6000-030 Ti Rod Ø6.0 x 30mm 2

SC-6000-040 Ti Rod Ø6.0 x 40mm 2

SC-6000-050 Ti Rod Ø6.0 x 50mm 2

SC-6000-060 Ti Rod Ø6.0 x 60mm 2

SC-6000-070 Ti Rod Ø6.0 x 70mm 2

SC-6000-080 Ti Rod Ø6.0 x 80mm 2

SC-6000-090 Ti Rod Ø6.0 x 90mm 2

SC-6000-030L Ti Rod Ø6.0 x 30mm, Lordosed 2








SC-6000-310-7B Ø5.5mm Lordosed & Straight Rods Caddy 1

SC-5500-030 Ti Rod Ø5.5 x 30mm 2

SC-5500-040 Ti Rod Ø5.5 x 40mm 2

SC-5500-050 Ti Rod Ø5.5 x 50mm 2

SC-5500-060 Ti Rod Ø5.5 x 60mm 2

SC-5500-070 Ti Rod Ø5.5 x 70mm 2

SC-5500-080 Ti Rod Ø5.5 x 80mm 2

SC-5500-090 Ti Rod Ø5.5 x 90mm 2









* The 6.0mm Lordosed & Straight Rods Caddy is shipped with the 6.0mm Degenerative Implant Set.

**The 5.5mm Lordosed & Straight Rods Caddy is shipped with the 5.5mm Degenerative Implant Set.


APEX Spine System Degenerative Instrument Set07.01957.401


SC-6000-100B-Z APEX Degenerative Instruments Case 1

SC-RG-0002-5 APEX Spine System Instruments IFU 1

SC-6000-01-A Axial Persuader 2

SC-6000-03 Ratcheting T-Handle 2

SC-6000-05 Long Rocker Forceps 1

SC-6000-06 Short Rocker Forceps 1

SC-6000-05-KLG Long Kelly Rocker for Large screws 1

SC-6000-06-KLG Short Kelly Rocker for Large screws 1

SC-6000-11 Rod Holder Forceps 1

SC-6000-12 Rod Clamp, Straight 1

SC-6000-16-S French Rod Bender 1

SC-6000-20-MC T20 Hexalobe Driver 1

SC-6000-30-M T30 Hexalobe Driver 2

SC-6000-30-2 T30 Starter Driver 2

SC-6000-41 Large Distractor 1

SC-6000-42 Large Compressor 1

SC-6000-44-1-H Small Sounding Probe, Straight (Hard Steel) 1

SC-6000-45 Starter Awl 1

SC-6000-48 Thoracic Pedicle Probe 1

SC-6000-49 Lumbar Pedicle Probe 1

S-6000-71-40-NC Ø4.00mm Tap - ¼” square end 1






SC-6000-75-U Universal Head Adjuster 1

SC-6000-89-PS Polyaxial Screwdriver with Tulip-Lock 2

SC-6000-89-DR Dedicated Reduction Polyaxial Screwdriver with Tulip-Lock 1

SC-6000-89-PLG Large Polyaxial Screwdriver with Tulip-Lock 1

SC-6000-91 Reduction Tab Remover 1

SC-6000-98 Regular Anti-Torque 1

SC-6000-98-LG Large Anti-Torque 1

SC-6000-02 Torque-Limiting T-Handle, 9.5 Nm 2

Torque-Limiting T-Handle07.01957.403


APEX Spine System Deformity Implant Set07.01956.402


SC-6000-410B-Z Deformity Implant Case 1


SC-6000-410-6B Deformity 1 Polyaxial Screw Caddy 1

SC-P6-4725 Poly Ti Pedicle Screw Ø4.75 x 25mm 6


















SC-6000-410-7B Deformity 2 Polyaxial Screw Caddy 1


















SC-6000-410-5B Large Polyaxial Screws and Iliac Connectors Caddy 1

SC-PF6-7760 Poly Ti Iliac Screw Ø7.75 x 60mm, Self-Tapping 2






SC-CC6-1600 Closed Iliac Connector 16mm 2



SC-CC6-3100 Closed Iliac Connector 31 mm 2

SC-CC6-3600 Closed Iliac Connector 36 mm 2

SC-6000-410-4B Hooks Caddy 1

SC-HB6-7050 Ti Bifid Hook, 5.0mm 2




SC-LH6-7050 Ti Wide Laminar Hook, 5.0mm 2




SC-H6-5050 Ti Laminar Hook, 5.0mm 2




SC-OL6-5050 Ti Offset Left Hook, 5.0mm 1




SC-OR6-5050 Ti Offset Right Hook, 5.0mm 1




SC-6000-310-3B Regular and Large Set Screw Caddy 1


S6-MPH95-T30L T30 Set Screw 11.0mm OD for Large Poly Screws 12

— Deformity Rods

SC-6000-300D Ti Rod Ø6.0 x 300mm 2

SC-6000-450D Ti Rod Ø6.0 x 450mm 2

APEX Spine System Deformity Implant Set, Continued


APEX Spine System Deformity Instrument Set07.01956.401


SC-6000-200B-Z APEX Deformity Instruments Case 1


SC-6000-07 Straight Implant Holder Forceps 1

SC-6000-08 Curved Implant Holder Forceps 1

SC-6000-09 Lateral Implant Holder Forceps 1

SC-6000-12 Rod Clamp, Straight 1

SC-6000-14-L In-Situ Coronal Rod Benders, Left Arm 1

SC-6000-14-R In-Situ Coronal Rod Benders, Right Arm 1

SC-6000-15-A Flat Rod Benders, Arm A 1

SC-6000-15-B Flat Rod Benders, Arm B 1

SC-6000-18 Rod Rotation Power Grip Holder 2

SC-6000-31 Laminar Elevator/Finder 1

SC-6000-32 Implant Pusher Dual Purpose 1

SC-6000-33 Pedicle Elevator/Finder 1

SC-6000-34 Rod Pusher 1

SC-6000-35 "C" Rod Pusher 1

SC-6000-38 Hook Starter 1

SC-6000-92 Reduction Tab Protector 6

SC-6000-94-L In-Situ Sagittal Rod Benders, Left Arm 1

SC-6000-94-R In-Situ Sagittal Rod Benders, Right Arm 1


APEX Spine System Cross Connectors Instrument and Implant Set07.01958.400


SC-6000-500B-Z APEX Cross Connector Implants & Instruments Case 1



SC-6000-02-C Torque-Limiting T-Handle, 8.5 Nm 2

SC-6000-10 Cross Connector Holder Forceps 1

SC-6000-20-MC T20 Hexalobe Driver 2

SC-6000-47 Cross Connector Measuring Card 1

SC-6000-99 Cross Connector Anti-Torque 1

SC-6000-500-2 APEX Cross Connector Caddy 1

SC-TX6-2428 Ti MultiSpan Cross Connector 24-28mm 2

SC-TX6-2833 Ti MultiSpan Cross Connector 28-33mm 2

SC-LX6-3139 Ti MultiSpan Cross Connector 31-39mm 2



SC-F6-1816 Ti Fixed Length Connector 16mm 2






APEX Spine System Vertebral Column Derotation Instrument Set07.01962.401


SC-6000-890B-Z Vertebral Column Derotation Instruments Case 1


SC-6000-801 Vertebral Derotator Post, w/ Ring 8

SC-6000-802 Derotator Interlink 1

SC-6000-802-SC Derotator Interlink Clamp (Part of SC-6000-802) (4)

SC-6000-802-MC Derotator Interlink Medium Clamp (Part of SC-6000-802) (2)

SC-6000-802-LC Derotator Interlink Long Clamp (Part of SC-6000-802) (2)

SC-6000-802-P Derotator Interlink Plate (Part of SC-6000-802) (1)

S-6000-805-100 Derotator Post Linking Rod - 100mm 4





SC-6000-808 Dual Purpose Derotator Handle 4


APEX Spine System Supplementary Implants Set 107.01956.403


SC-6000-610-Z Supplementary Implant Case 1 1

SC-6000-610-1 Monoaxial Screw Caddy 1

SC-M6-4725 Mono Ti Pedicle Screw Ø4.75 x 25mm 4





SC-MF6-5530 Mono Ti Pedicle Screw Ø5.50 x 30mm, Self-Tapping 2













--- Monoaxial Screw Instruments

SC-6000-85 Monoaxial Screwdriver 1

SC-6000-90-S Monoaxial Screwdriver Tightening Key 1

SC-6000-610-3 Rod-to-Rod Connectors Caddy 1

SC-5500-D5060 Side-by-Side Rod Connector Ø5.5 to Ø5.5mm 2



SC-5500-D5020 Demi Side-by-Side Rod Connector Ø5.5 to Ø5.5mm 2



SC-5500-T5030 Tandem Rod Connector Ø5.5 to Ø5.5mm 2




SC-6000-610-4 Miscellaneous Implants Caddy 1

SC-P60-112 2mm Open Washer for Large Polyaxial Pedicle Screws 4

SC-P60-212 2mm Closed Washer for Large Polyaxial Pedicle Screws 4


APEX Spine System Supplementary Implants Set 207.01956.404


SC-6000-710-Z Supplementary Implant Case 2 1

SC-6000-710-1 Ø4.75mm Reduction Polyaxial Screws Caddy 1

SC-PR6-4725 Poly Ti Pedicle Reduction Screw Ø4.75 x 25mm 2





SC-6000-710-2 Ø5.5mm Reduction Polyaxial Screws Caddy 1






SC-6000-710-3 Ø6.25mm & Ø7mm Reduction Polyaxial Screws Caddy 1









SC-6000-710-4 Size-Neutral Caddy for Regular Screws 1

Any Any (up to 16)

SC-6000-710-5 Size-Neutral Caddy for Reduction Screws 1

Any Any (up to 16)


APEX Spine System Supplementary Rods Set07.01956.405


SC-6000-210-Z Supplementary Rod Case 1


SC-5500-300D Ti Rod Ø5.5 x 300mm, Deformity 4


SC-5500-CR300 CoCr Rod Ø5.5 x 300mm 4






SC-5500-600D Ti Rod Ø5.5 x 600mm, Deformity

SC-5500-CR600 CoCr Rod Ø5.5 x 600mm

SC-6000-600D Ti Rod Ø6.0 x 600mm, Deformity

SC-6000-CR600 CoCr Rod Ø6.0 x 600mm

Also Available to Order:


APEX Spine System Optional InstrumentsMay be ordered individually by part number

Catalog Number Description Quantity Recommended in Kit

SC-6000-01 Pistolgrip Persuader 1

SC-6000-01-ALG Large Axial Persuader 1

SC-6000-01-AT Axial Persuader T-Handle 1

SC-6000-03-S Ratcheting Straight Handle 1

SC-6000-04-B Fixed Ball Handle 1

SC-6000-04-S Fixed Straight Handle 1

SC-6000-13 Rod Clamp, Offset 1

SC-6000-20-1 Nurse's Wrench T20 1

SC-6000-30-1 Nurse's Wrench T30 1

SC-6000-30-3 T30 Self-retaining Driver with Dedicated Handle 1

SC-6000-43 Sounding Probe, Curved (Soft steel) 1

SC-6000-43-H Sounding Probe, Curved (Hard steel) 1

SC-6000-44 Sounding Probe, Straight (Soft steel) 1

SC-6000-44-H Sounding Probe, Straight (Hard steel) 1

SC-6000-44-1 Small Sounding Probe, Straight (Soft steel) 1

SC-6000-44-1-SH Small Sounding Probe, Straight (Super Hard) 1

SC-6000-49-S Straight Lumbar pedicle probe 1

SC-6000-49-S-M Straight Lumbar pedicle probe, Modular 1

SC-6000-53 Adult pedicle probe 1

SC-6000-54 Iliac pedicle probe 1

SC-6000-71-47 Ø4.75mm Cannulated Tap - ¼” square end 1






SC-6000-75-LG Large Head Adjuster 1

SC-6000-85 Monoaxial Screwdriver 1

SC-6000-90-S Monoaxial Screwdriver Tightening Key 1

SC-6000-92 Reduction Tab Protector 6

SC-6000-95 Handheld Rod Cutter 1

SC-6000-96 Table-Top Rod Cutter 1

SC-6000-850 Derotation Tube 6

SC-6000-983 Regular Anti-Torque w/ Large Cannula 1


Warnings, Precautions, & Possible Adverse Effects

USAGE

WARNINGS1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape, and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing.

2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load-sharing devices which are used to obtain alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to metal fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure.

3. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerates the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion often accelerates fatigue fracture of implants.

The amount of metal compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, etc., which come into contact with other metal objects, must be made from like or compatible metals.

4. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure:

A. The patient’s weight. An overweight or obese patient can produce loads on the device that can lead to failure of the appliance and the operation.

B. The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes heavy lifting, muscle strain, twisting, repetitive bending, stooping, running, substantial walking, or manual labor, he/she should not return to these activities until the bone is fully healed. Even with full healing, the patient may not be able to return to these activities successfully.

C. A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications.

D. Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary remedy.

E. Foreign body sensitivity. The surgeon is advised that no preoperative test can completely exclude the possibility of sensitivity or allergic reaction. Patients can

develop sensitivity or allergy after implants have been in the body for a period of time.

F. Smoking. Patients who smoke have been observed to experience higher rates of pseudo-arthrosis following surgical procedures where bone graft is used. Additionally, smoking has been shown to cause diffuse degeneration of intervertebral discs. Progressive degeneration of adjacent segments caused by smoking can lead to late clinical failure (recurring pain) even after successful fusion and initial clinical improvement.

PRECAUTIONS1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted metal implant should never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage. Reusing an implant can potentially cause cross contamination. It is advised to utilize new implant of current design.

2. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of metal implants should only be done with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease the fatigue life and may cause failure.

3. CONSIDERATIONS FOR REMOVAL OF THE IMPLANT AFTER HEALING. If the device is not removed after the completion of its intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from postoperative trauma;


(4) Bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risks involved with a second surgery.

4. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient’s ability and willingness to follow instructions are among the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant, and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sports participation. The patient should understand that a metallic implant is not as strong as normal healthy bone and could loosen, bend and/or break if excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may migrate and damage the nerves or blood vessels. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation.

5. CORRECT PLACEMENT OF ANTERIOR SPINAL IMPLANT. Due to the proximity of vascular and neurologic structures to the implantation site, there are risks of serious or fatal hemorrhage and risks of neurologic damage with the use of this product. Serious or fatal hemorrhage may occur if the great vessels are eroded

or punctured during implantation or are subsequently damaged due to breakage of implants, migration of implants or if pulsatile erosion of the vessels occurs because of close apposition of the implants.

6. IMPLANTS FATIGUE. Based on the fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact the performance of the system.

7. PREVIOUS SPINAL SURGERY. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.

POSSIBLE ADVERSE EFFECTS1. Bending or fracture of implant.2. Loosening of the implant.3. Metal sensitivity, or allergic reaction to a

foreign body.4. Infection, early or late.5. Nonunion, delayed union.6. Decrease in bone density due to stress

shielding.7. Pain, discomfort, or abnormal sensations

due to the presence of the device.8. Nerve damage due to surgical trauma

or presence of the device. Neurological difficulties including bowel and/or bladder dysfunction, impotence, retrograde ejaculation, and paraesthesia.

9. Bursitis.10. Paralysis.11. Dural tears experienced during surgery

could result in the need for further surgery for dural repair, a chronic CSF leak or fistula, and possible meningitis.

12. Death.13. Vascular damage due to surgical trauma

or presence of the device. Vascular damage could result in catastrophic or fatal bleeding. Malpositioned implants adjacent to large arteries or

veins could erode these vessels and cause catastrophic bleeding in the late postoperative period.

14. Screw back out, possibly leading to implant loosening, and/or reoperation for device removal.

15. Damage to lymphatic vessels and/or lymphatic fluid exudation.

16. Spinal cord impingement or damage.17. Fracture of bony structures.18. Degenerative changes or instability in

segments adjacent to fused vertebral levels.

Disclaimer:

This documentation is intended exclusively for physicians and is not intended for laypersons.

Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part.

Please refer to the package inserts for imp

APEX Spine System Surgical Technique - Zimmer Biomet€¦ · 4 APEX Spine System – Degenerative...

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