Biomet Vision Unilateral Fixator Surgical Technique...Additional indications for the Biomet® Vision...

Surgical Technique

Biomet® Vision™ Unilateral Fixator

Contents

Introduction .................................................... Page 1

Design Features.............................................. Page 7

Instruments .................................................... Page 8

Standard Fixator Technique ............................ Page 9

Arc Clamp With Standard ................................ Page 15

Fixator Technique

Ankle Fixator And Variable Ankle .................... Page 16

Fixator Technique

System Assembly/Disassembly ...................... 2

Suggested Screw Site Care/Sterilization ......... Page 24

Product Information ........................................ Page 25

Further Information ......................................... Page 29

1

Introduction

The Biomet Vision Unilateral Fixator is an external fixation

device intended for use in the treatment of bone conditions

including leg lengthening, osteotomies, arthrodesis and fracture

fixation addressing periarticular, diaphyseal and other fractures

amenable to temporary or definitive external fixation.

The Biomet Vision Unilateral Fixator incorporates

lightweight carbon fiber materials into its frame to allow for

unobstructed fracture visualization and provide optimal fixation.

The system includes multiple frame configurations

- the Standard Fixator, Ankle Fixator, Variable Ankle Fixator and

Arc Clamp with Standard Fixator - that all share a unique carbon

central body design. The radiolucent central body includes

serrated rotational and dual locking connectors with locking

connector bolts that provide a mechanical locking mechanism

with up to 120° of controlled fracture reduction in any plane.

INDICATIONS

The DynaFix Vision Unilateral System and the DynaFix Vision

External Fixation System are external fixation device intended

for use in the treatment of bone conditions including leg

lengthening, osteotomies, arthrodesis, fracture fixation, and other

bone conditions amenable to treatment by use of the external

fixation modality.

Additional indications for the Biomet® Vision FootRing System,

a sub system of the DynaFix Vision External Fixation System

include:

• Correction of deformity

• Revision procedures where other treatments or devices

have been unsuccessful

• Bone reconstruction procedures

• Fusions and replantations of the foot

• Charcot reconstruction and Lisfranc dislocations

• Ankle distraction (arthrodiastasis)

CONTRAINDICATIONS

Patients with mental or neurologic conditions who are unwilling

or incapable of following postoperative care instructions.

Introduction (Continued)

Standard Fixator Complete (Catalog #20150)

The standard fixator is comprised of a telescoping fixator clamp

(female), fixed clamp (female), two dual locking connectors

and two rotational locking connectors (male). The telescoping

fixator clamp and fixed clamp are coupled to a rotational locking

connector and secured by means

of locking setscrew. The two dual locking connectors are

coupled together with opposite ends connecting to a rotational

locking connector. Rotational locking connectors and dual

locking connectors are coupled together by means of a

locking connector bolt. Each component is secured using a

torque wrench.

Telescoping Fixator Clamp with CD Mechanism (1 each)

Rotational Locking Connectors(2 each)

Locking Connector Bolt (3 each)

Dual Locking Connector (2 each)

Fixed Clamp (1 each)

2

3

Ankle Fixator Complete (Catalog #20380) And Variable

Ankle Fixator Complete (Catalog #20390)

The ankle and variable ankle fixator are comprised of a

telescoping fixator clamp (female), ankle clamp (female), two

dual locking connectors and two rotational locking connectors

(male). The telescoping fixator clamp and ankle clamp are

coupled to a rotational locking connector and secured by

means of locking setscrew. The two dual locking connectors

are coupled together with opposite ends connecting to a

rotational locking connector. Rotational locking connectors

and dual locking connectors are coupled together by means of

a locking connector bolt. The ankle clamp pivot bolt is locked

in the direction of the yellow arrow etched on the clamp. The

telescoping fixator clamp and central body component should

be parallel to the long axis of the tibia medially. Positioning

the fixator in this fashion will ensure free excursion of the

telescoping fixator clamp and provide for predictable

intra-operative adjustments.



Variable Ankle Fixator complete offers a variable position talar pin clamp that provides increased flexibility when applying the ankle fixator to the patient.



Ankle Clamp


Arc Clamp (Catalog #20300) With Standard Fixator

Complete (Catalog #20150)

The arc clamp is packaged separately and used in conjunction

with the standard fixator. It can be substituted for either a

telescoping fixator clamp or fixed clamp. The rotational locking

connector (male) attaches to the female coupler of the arc

clamp and is secured by means of a locking setscrew and

torque wrench. The arc clamp has two silver template clamps

(shown on page 15) to allow use of soft tissue instrumentation

during bone screw application and two black bone screw

clamps for securing bone screws. All locking components are

secured with the torque wrench.




Arc Clamp

Black Bone ScrewClamps


4

5

Individual Frame Components

Dual Locking Connectors

• Two dual locking connectors are coupled together by means of a locking connector bolt

• Contain serrated discs at each end of the component, which interface with the serrated discs of the rotational

locking connectors

• Serrated discs provide 60° of articulation from neutral in any plane (120° total)

Rotational Locking Connectors

• Two rotational locking connectors are coupled to a dual locking connector by means of the locking

connector bolt

• Contain a single serrated disc at one end of the component and a male rotational coupler at the other end

• Rotational coupler (male) can interface with multiple female coupler components

• Provides 360° of rotation about the axis of the fixator

• Serrated disc interface with the dual locking connector and will accommodate 60° of articulation from

neutral in any plane (120° total)

• All locking components are definitively secured using a torque wrench

Fixed Clamp

• Fixed clamp (female) is coupled to a rotational locking connector (male) of the Standard Fixator Complete only

• Locking points include two clamp cover locking bolts and one locking setscrew

• Two clamp cover locking bolts secure bone screws to the clamp

• Single locking setscrew secures the fixed clamp to the rotational locking connector

• All locking components are definitively secured using a torque wrench

Locking Setscrew

Clamp Cover Locking Bolts(2 each)


Telescoping Fixator Clamp

• Comprised of a pre-assembled compression/distraction (C/D) mechanism, telescoping fixator clamp cover,

locking setscrews, clamp cover locking bolts and straight clamp

• Coupled to the rotational locking connector (male) of the Ankle, Variable Ankle and Standard Fixators

• Provides up to 4.5cm of compression/distraction over the straight clamp when positioned parallel to the

long axis of the bone

• Locking points include two clamp cover locking bolts and four locking setscrews

• Two clamp cover locking bolts secure bone screws to the clamp

• Three of the four locking setscrews secure the telescoping fixator clamp cover to the straight clamp

and the remaining locking setscrew secures the straight clamp to the rotational locking connector

• Telescoping fixator clamp cover can be removed for application of MRI Safe SLM Rapid Rod-to-Screw Clamp

(Catalog #14605) or MRI Safe SLM Rapid Rod-to-Rod Clamp (Catalog #14600) directly to the Straight Clamp

• All telescoping fixator clamp locking components are definitively secured using a torque wrench

CD Mechanism

Telescoping Fixator Clamp Cover

Locking Setscrews (4 each)

Clamp Cover Locking Bolts (2 each)

Straight Clamp

Distraction limit

Catalog #14605

Total length = 4.5cm

Straight Clamp shown with telescoping fixator clamp cover removed

Each line = 2mm

6

7

Design Features

• Carbon fiber components are radiolucent, strong and lightweight

• Unique central body design permits controlled fracture reduction in any plane

• System is completely modular, allowing for a variety of frame configurations that address periarticular and diaphyseal applications

• Serrated locking connectors provide a mechanical locking mechanism with up to 120° of articulation in any plane

• Universal Application - Ability for fixator to be used on either the right or left side of body

• New Telescoping Fixator Clamp cover can be removed for application of Biomet Vision Pin-to-Bar to Straight Clamp

• New Variable Ankle Fixator complete offers a variable position talar pin clamp that provides increased flexibility when applying the ankle fixator to the patient

Instruments

The following instrumentation is recommended for use with

the Biomet Vision Unilateral Fixator.

NOTe: The use of a Torque Wrench (90in-lbs) is required to

ensure proper locking of the system. Use of traditional 5mm

Allen Wrench or T-Wrench is prohibited, as this may result in

undue stress to the carbon fiber materials.

4mm T-Wrench (provisional tightening) Catalog #21020

Required when tightening the pivot bolt on Ankle Clamp and

Variable Ankle Clamp.

L-Torque Wrench: Catalog #21030Used for definitive tightening locking connector bolts, locking setscrews and clamp cover locking bolts.

Additional Instrumentation

T-Wrench for bone screws: Catalog #03125

5mm Allen Wrench: Catalog #03110

4mm Allen Wrench: Catalog #02555

4mm hex

4mm hex

5mm hex

4mm hex

Bullet Wrench (Provisional tightening) Catalog #21015

8

9

Standard Fixator Technique

Step #1

Pre-operative planning is recommended prior to the application

of this device. Assess potential screw site location based on

available bone stock and soft tissue considerations. Additional

modules may be utilized for horizontal screw placement or

fracture specific applications. Selected screw sites must

accommodate the length of the central body components. All

constructs should include at least one telescoping fixator clamp

that should be positioned parallel to the long axis of the bone

to which it is to be secured. Axial alignment of the telescoping

fixator arm helps assure free excursion (compression/distraction).

Fixator components are used as templates. Prep and drape in

routine fashion.

Figure 1

Step #2

Obtaining a preliminary reduction is recommended. Templating

with the fixator body, adjust the rotational locking connector

to avoid limb interference with bolts. Add or remove knuckles

to gain length or accommodate unusually short limbs. The

first bone screw is generally inserted in the shortest or most

difficult fragment. Assess available bone stock for desired screw

position. (Figures 1 & 2)

NOTe: When possible, allow 4cm of distance between fracture

site and first bone screw.

Figure 2

Step #3

A 1cm incision is made and blunt dissection continued to bone.

(Figure 3)

Figure 3

Standard Fixator Technique (Continued)

Step #4

The trocar and appropriate length soft tissue guide are then

utilized to identify the center of the bone and to establish the

orientation of the screw tract to be pre-drilled. The orientation

of the insertion of the bone screws should be perpendicular to

the long axis of the bone. (Figure 4) Site of proximal screws is

predicated by the proximal screw clamp. Place the fixator over

the proximal limb area and template all screws outside the zone

of soft tissue injury to prevent contamination of fracture through

the screw.

NOTe: Allow a minimum of 4cm of distance between fracture site

and first bone screw.

Figure 4

Step #6

The soft tissue guide is tapped with a mallet to engage the soft

tissue guide with bone. (Figure 5)

Figure 6

Step #7

Insert appropriate drill guide into the soft tissue guide. (Figure 6)

NOTe:

Drill Guide Drill Bit Screw

4.8mm 4.8mm 6/5mm (Cortical)

3.2mm 3.2mm 6/5mm (Cancellous)

3.2mm 3.2mm 4.5/3.5mm (Cortical)

2.9mm 2.9mm 3.5/3.2mm (Cortical)Step #5

Once the screw site is selected, use gentle pressure to maintain

contact between the soft tissue guide and the cortex of the bone.

Extract the trocar.

Figure 5

10

11

Step #8

Insert matching drill bit with drill stop into the drill guide. Drill the

near cortex. Drilling is halted upon contact with the far cortex. Be

sure pre-drilled screw tract is perpendicular to the long axis of

the bone. (Figure 7)

Figure 8

Step #10

After bi-cortical penetration of the drill, the drill bit and drill guide are

withdrawn. Maintain contact and position of the soft tissue guide.

Figure 10

Step #11

The appropriate length screw is then inserted through the soft

tissue guide. The bone screw T-Wrench (Catalog #03125) is used

to advance the screw into bone. To obtain optimal purchase,

all bone screws must be bi-cortical with no less than 2mm

protruding from the far cortex and about 5mm remaining outside

the near cortex. Image intensification is utilized to confirm depth

of penetration. (Figure 10)

For short segment, clamp bone screw holes 1 & 3, 3 & 5 or 2 & 4

may be selected. Translocation of clamp on pin cluster is possible

(as necessary).

NOTe: Care must be taken to avoid over-penetration. Due to the

tapered design, bone screws must not be backed out or they will

lose purchase.

Step #9

Upon contact with the far cortex, the drill stop is re-positioned and

secured approximately 5mm from the base of the drill guide. The

drill stop will prevent over penetration of the drill bit into underlying

soft tissue structures. The far cortex is then drilled. (Figures 8 & 9)

Figure 9

Figure 7


12

Step #12

Loosen the clamp cover locking bolts of the fixed clamp such that

the soft tissue guide and existing bone screw are accommodated.

At this point, a second bone screw may be introduced into the

same female clamp to insure a parallel relationship of the fixed

clamp to bone. Repeat steps 3-11 making sure to snug down

the female clamp cover locking bolts to prevent toggle of the soft

tissue guides within the clamp. This helps maintain proper bone

screw alignment. (Figure 11)

Step #13

It is also possible at this point to address the opposing bone

screw cluster. The locking connector bolts and locking setscrews

are provisionally tightened. Proceed to opposite telescoping fixator

clamp. Identify and secure screw placement following steps 3-11.

Align telescoping fixator clamp and fixed clamp such that they are

parallel to the long axis of the bone into which they are inserted.

Insert soft tissue guide and trocar, snug down clamp cover

locking bolts, and proceed with subsequent bone screw insertion

steps 3-11. (Figure 12)

NOTe: Ensure at least 1cm of space is between telescoping cover and straight clamp.

Step #14

Remove soft tissue guides and tighten clamp cover locking bolts

providing at least 3cm clearance between fixator body and skin

surface. (Figure 13)

Use of a Torque Wrench (90in-lbs) is required to ensure proper locking of the system. Use of traditional 5mm Allen Wrench or T-Wrench is prohibited, as this may result in undue stress to the carbon fiber materials. (Figure 14)

Figure 14

Figure 13

NOTe: Ensure at least 3cm clearance between fixator body and skin surface.

Figure 11

Figure 12

Figure 16

Figure 19

13

Step #15

Final reduction may be addressed systematically. Length is

accomplished by distracting (manually or incrementally) the CD

mechanism from the telescoping fixator clamp in the direction of

the arrow, counterclockwise. (Figure 15)

NOTe: For angular or translational adjustments there should be a

corresponding adjustment in length.

Figure 15

Turn counterclockwise to distract

NOTe: If distraction (or compression) is desired, the proximal locking setscrew must first be definitively tightened with a torque wrench.

NOTe: If distraction (or compression) is desired, ensure the two distal locking setscrews are NOT definitively tightened. Upon desired distraction, lock the setscrews with a torque wrench.

Step #16

Rotation about the axis of the fixator may be achieved by

releasing the locking setscrew of the rotational locking connectors

(male). (Figure 16)

Step #17

Each dual locking connector will provide angular adjustments

in two planes relative to fixator position as applied to the bone.

Utilize the dual locking connector most adjacent to fracture for

angular corrections. (Figures 17 & 18)

Step #18

Translational adjustment is performed by releasing two opposing

dual locking connectors in the same plane as desired correction.

Translation can also be addressed by utilizing the half pins

already inserted into the bone to be translated. (Figure 19)

Figure 17

Figure 18


14

Standard Fixator shown with Straight Clamp and SLM Rapid

Rod-to-Screw Clamps (Catalog #14605) applied.

NOTe: CD Mechanism cannot be used for this construct.

Optional Standard Fixator Technique Configurations

MRI SAFE SLM Rapid Rod-to-Screw Clamps can be applied to

opposite ends of the Straight Clamp.

Arc Clamp With Standard Fixator Technique

15

The arc clamp may be substituted for either a telescoping fixator

clamp or a fixed clamp component from the Standard Fixator,

where horizontal bone screw placement is desired.

Attach the arc clamp (female) coupler to the rotational locking

connector (male) and secure the single locking setscrew with a

torque wrench.

The arc clamp offers two silver template clamps (Figure 20)

to allow for soft tissue instrumentation during bone screw

application. Additionally, the two black bone screw clamps will

secure the bone screws.

The arc clamp should be applied following steps 3-11

(page 9-11) from Standard Fixator Technique. Assess

selected diaphyseal screw sites to assure a parallel relationship

between telescoping fixator clamp (or fixed clamp) and the bone.

Insert diaphyseal bone screws following steps 3-12 (page 9-12)

from Standard Fixator Technique. Obtain reduction and definitively

tighten all fixator-locking bolts with a torque wrench.

NOTe: Use of a Torque Wrench (90in-lbs) is required to ensure

proper locking of the system. Use of traditional 5mm Allen

Wrench or T-Wrench is prohibited, as this may result in undue

stress to the carbon fiber materials.

Optional Arc Clamp Technique Configuration

Arc Clamp frame shown with Straight Clamp and SLM

Rapid Rod-to-Screw Clamps (Catalog #14605) applied.


Figure 20

Alternatively, a Variable Angle Screw Clamp can be affixed to bone screw.

Step #1

After achieving a preliminary pre-op reduction, the first screw

to be introduced should be positioned medially in the talar neck,

so that it is parallel to the dome of the talus following steps 3-9

(pages 9-11) of Standard Fixator Technique. (Figure 21)

NOTe: If using Variable Ankle Fixator, reference page 20 for

first screw insertion detail

Step #2

After bi-cortical penetration, release the 3.2mm drill bit and

evaluate its position fluoroscopically to confirm a parallel

relationship to the talar dome. Reattach drill bit to drill and

extract. After bi-cortical penetration of the drill, the drill bit and

drill guide are withdrawn. Maintain contact and position of the

soft tissue guide.

Step #3

Attach the ankle clamp onto the talar bone screw and screw

guide with the window of the device positioned medially and

anterior to facilitate lateral radiographic evaluation. Clamp cover

locking bolts of the ankle clamp must be facing distally for

access to locking components. (Figure 22)

Step #4

Using the ankle clamp as a template, select second screw position

in the calcaneus allowing for desired plantar/dorsi flexion. Repeating

steps 3-11 (pages 9-11) of Standard Fixator Technique, insert

second bone screw. Confirm bone screw position and depth of

penetration utilizing image intensification. (Figure 22)

Step #5

Spatially relocate the talus under the tibia and position remaining

bone screws through the telescoping fixator arm in the tibial diaphysis

perpendicular to the long axis of the tibia. Secure clamp cover locking

bolts (Figure 23) with a torque wrench for definitive tightening.

Ankle Fixator And Variable Ankle Fixator Technique

16

Figure 23

NOTe: Clamp Cover Locking Bolts must face distal

Figure 21 Figure 22

17

Step #6

Attach fixator body to ankle clamp. The ankle clamp (female)

coupler is fully seated into the rotational locking connector (male).

These components are assembled and secured by means of a

locking setscrew and torque wrench. (Figure 24)

Step #7

Attach telescoping fixator clamp to central body. Insert soft

tissue guides and drill guides, following Standard Fixator

Technique steps 3-12 (pages 9-12). (Figures 25 & 26)

NOTe: Ensure at least 3cm clearance

between fixator body and skin surface

Figure 25

Figure 26

Figure 24

Male Female

NOTe: Bone screws shown inserted

Ankle Fixator And Variable Ankle Fixator Technique (Continued)

18

Use of a Torque Wrench (90in-lbs) is required to ensure

proper locking of the system. Use of traditional 5mm Allen

Wrench or T-Wrench is prohibited, as this may result in

undue stress to the carbon fiber materials. (Figure 27 & 28)

Figure 27

Figure 28

NOTe: If distraction (or compression) is desired, the proximal locking setscrew must first be definitively tightened with a torque wrench.

NOTe: If distraction (or compression) is desired, ensure the two distal locking setscrews are NOT definitively tightened. Upon desired distraction, lock the setscrews with a torque wrench.

Step #9

Final reduction may be addressed systematically. Length is

accomplished by distracting (manually or incrementally) the CD

mechanism from the telescoping fixator clamp in the direction of

the arrow, counterclockwise. (Figure 29)

NOTe: For angular or translational adjustments there should be a

corresponding adjustment in length.

Figure 29

Turn counterclockwise to distract

19

Step #10

The pivot bolt on the ankle clamp is tightened in the direction

of the yellow arrow etched on the clamp with use of the 4mm

T-Wrench (Catalog #21020) only. (Figure 30)

NOTe: (Cortical Screws placed in Cancellous Bone) When placing

a cortical screw into the neck of the talus, you will start with a soft

tissue sleeve and a 3.2mm drill guide placed in the appropriate

location on the neck of the talus. Under power a 3.2mm drill bit will

be drilled through the medial cortex and through the lateral cortex.

Next, remove the 3.2mm drill sleeve and replace it with a 4.8mm

drill sleeve. Under power a 4.8mm drill bit will be used to drill

through the medial cortex only. The 4.8mm drill sleeve is removed

and the appropriate 6/5mm cortical bone screw is inserted into the

soft tissue sleeve. The screw is inserted past the lateral cortex by

two threads. The talus and calcaneus portion of the ankle clamp is

attached to the screw that is in place in the neck of the talus. A soft

tissue sleeve and 3.2mm drill sleeve is placed in the calcaneus part

of the ankle clamp and the procedure is repeated in the calcaneus.

NOTe: For left application, tighten counterclockwise, as shown

(Figure 31). For right application, tighten clockwise.

This is the only portion of the ankle clamp that requires use

of a 4mm T-Wrench (Catalog #21020) for definitive tightening.

Do not use the Torque Wrench to tighten.

Figure 30

Figure 31

Ankle Fixator And Variable Ankle Fixator Technique (Continued)

20

Variable Ankle Fixator Complete (Catalog #20390)

Offers a variable position talar pin clamp that provides increased

flexibility when applying the ankle fixator to the patient. (Figure 32)

Vision Unilateral Ankle Fixator Post-Operative X-Rays

Figure 32

25°

25°

0°Neutral

Variable ball joint

M/L Plane

A/P Plane

The Variable Ankle Fixator ball joint provides 50° cone of angulations. From neutral position, the ball joint provides 25° angulations.

21

Variable Ankle Fixator shown with MRI SAFE SLM

Rapid Rod-to-Screw Clamps (Catalog #14605) and MRI SAFE SLM

Rapid Rod-to-Rod Clamp (Catalog #14600) applied to Straight Clamp.


Ankle Fixator shown with Straight Clamp and MRI SAFE SLM

Rapid Rod-to-Screw Clamps (Catalog #14605) applied.


System Assembly/Disassembly

22

The Biomet Vision Unilateral Fixator is shipped fully assembled,

but can be adjusted to accommodate a desired length.

Removing A Dual Locking Connector

• To remove a dual locking connector, two locking bolts must be fully removed

• While removing the locking bolts, components should not be held together, but rather should be apart so that threads are only engaged with a single component at a time

• With the two locking bolts removed the dual locking connector is put aside and the frame can be reassembled

• To reassemble the frame, the locking bolt should be fully threaded through the remaining dual locking connector before it engages the threaded component of the rotational locking connector or dual locking connector

• By fully threading the locking bolt through the first component before engaging the second, you will ensure proper seating of the bolt to secure the components together

• This step is repeated to connect the other half of the dual locking connector

• All locking components should be facing away from the extremity to which the frame is applied. This will ensure that you have access to definitively lock all components once the frame is properly positioned

Correct Incorrect

NOTe: Locking connector bolt should be flush against the dual locking connector when turning counterclockwise to remove.

23

Adding A Dual Locking Connector

• To add a dual locking connector, one locking bolt must be fully removed

• While removing the locking bolts, components should not be held together, but rather should be apart so that threads are only engaged with a single component at a time

• With the locking bolt removed, the frame can be reassembled with the additional dual locking connector

• To reassemble the frame, the locking bolt should be fully threaded through the remaining dual locking connector before it engages the threaded component of the rotational locking connector or dual locking connector

• By fully threading the locking bolt through the first component before engaging the second, you will ensure proper seating of the bolt to secure the components together

• This step is repeated to connect the other half of the dual locking connector

• All locking components should be facing away from the extremity to which the frame is applied. This will ensure that you have access to definitively lock all components once the frame is properly positioned

Shorter Constructs With (1) Dual Locking Connector Removed

Suggested Screw Site Care/Sterilization

At the conclusion of fixator application and fracture reduction,

wounds are dressed in routine sterile fashion. Care should

be taken to ensure all fixator fittings are securely tightened.

Dry sterile gauze is wrapped around the shanks of the bone

screws to prevent pistoning of the soft tissues on the bone

screws. Once wounds have healed and sutures are removed,

routine postoperative screw site care is recommended. Screw

sites should be monitored during subsequent clinic visits.

All fixator fittings should be evaluated for tightness during

subsequent clinic visits.

The Biomet Vision Unilateral Fixator is provided nonsterile

and must be sterilized prior to use. Repeated sterilization of

carbon fiber reinforced epoxy is not recommended.

All packaging materials must be removed prior to sterilization.

All fixator components should be sterilized in a loosened state

such that components may move freely.

The following steam sterilization parameters are recommended.

Cycle

Vacuum Steam

Temperature: 270°F/132°C

Time: Eight minutes

NOTe: Allow for cooling

CAUTION: Federal Law (USA) restricts this device to sale by

or on the order of a physician

NOTe: Patents Pending. Made in the USA

WARNING: This device is not approved for screw attachment

or fixation to the posterior elements (pedicles) of the cervical,

thoracic, or lumbar spine. See package insert for full prescribing

information.

24

25

Product Information

Top Tray

Catalog # Description

20150 Standard Fixator Complete

20380 Ankle Fixator Complete

20390 Variable Ankle Fixator Complete

20300 Arc Clamp

Soft Tissue Guides

03080 40mm Soft Tissue Guide



Drill Guides

03060 4.8mm Drill Guide



Drill Bits

03020 4.8mm Drill Bit 180mm

(Complete)

03010 4.8mm Drill Bit 240mm (Complete)

03225 4.8mm Cannulated Drill Bit w/1.6 P/T

Guide Wire




Instruments

03075 Trocar

03125 T-Wrench for bone screws

21030 L-Torque Wrench (definitive tightening)

21015 Bullet Wrench (provisional tightening)

21020 4mm T-Wrench (provisional tightening)

Additional Components

Catalog # Description

06240 Variable Angle Screw Clamp

14605 MRI SAFE SLM Rapid Rod-to-Screw Clamp

14600 MRI SAFE SLM Rapid Rod-to-Rod Clamp

14160 150mm Carbon Rod








02555 4mm Allen Wrench

03110 5mm Allen Wrench

21006 Torque Wrench Replacement Tip

03195 General Surgical Tray

Product Information (Continued)

26

6/5 Tapered Cortical Bone Screws With 6mm Shank

Catalog # Thread Type/Thread Length

A60-09030 Cortical - 90/30

A60-09040 Cortical - 90/40

A60-10030 Cortical - 100/30

A60-10040 Cortical - 100/40

A60-11030 Cortical - 110/30

A60-11040 Cortical - 110/40

A60-11050 Cortical - 110/50

A60-12040 Cortical - 120/40

A60-13030 Cortical - 130/30

A60-13040 Cortical - 130/40

A60-13050 Cortical - 130/50

A60-13060 Cortical - 130/60

A60-13070 Cortical - 130/70

A60-14080 Cortical - 140/80

A60-14090 Cortical - 140/90

A60-15030 Cortical - 150/30

A60-15040 Cortical - 150/50

A60-15040T Cortical - 150/40

A60-15050 Cortical - 150/50

A60-15050T Cortical - 150/50

A60-15060 Cortical - 150/60

A60-16030 Cortical - 160/30

A60-16040 Cortical - 160/40

A60-16050 Cortical - 160/50

A60-17040 Cortical - 170/40

A60-17060 Cortical - 170/60

A60-18030 Cortical - 180/30

A60-18040 Cortical - 180/40

A60-18050 Cortical - 180/50

A60-18060 Cortical - 180/60

A60-20050 Cortical - 200/50

A60-20060 Cortical - 200/60

A60-22030T Cortical - 220/30

A60-22040T Cortical - 220/40

A60-22050 Cortical - 220/50

A60-22050T Cortical - 220/50

A60-22060 Cortical - 220/60

A60-22060T Cortical - 220/60

A60-25030T Cortical - 250/30

A60-25040T Cortical - 250/40

A60-25050T Cortical - 250/50

A60-25060T Cortical - 250/60

A60-25080T Cortical - 250/80

A60-25010T Cortical - 250/100

A60-30060 Cortical - 300/60

6/5 Tapered Cancellous Bone Screws With 6mm Shank


B60-09030 Cancellous - 90/30

B60-10030 Cancellous - 100/30

B60-10040 Cancellous - 100/40

B60-11040 Cancellous - 110/40

B60-11050 Cancellous - 110/50

B60-12040 Cancellous - 120/40

B60-12060 Cancellous - 120/60

B60-13040 Cancellous - 130/40

B60-13050 Cancellous - 130/50

B60-13060 Cancellous - 130/60

B60-14050 Cancellous - 140/50

B60-15060 Cancellous - 150/60

B60-16070 Cancellous - 160/70

B60-16090 Cancellous - 160/90

B60-17080 Cancellous - 170/80

B60-18090 Cancellous - 180/90

B60-18010 Cancellous - 180/100

B60-20080 Cancellous - 200/80

B60-20090 Cancellous - 200/90

27

4.5/3.5 Tapered Cortical Bone Screws With 6mm Shank


A45-06020 Cortical - 60/20

A45-07020 Cortical - 70/20

A45-08020 Cortical - 80/20

A45-08030 Cortical - 80/30

A45-08040 Cortical - 80/40

A45-10020 Cortical - 100/20

A45-10040 Cortical - 100/40

A45-12020 Cortical - 120/20

A45-12040 Cortical - 120/40

3.5/3.2 Tapered Cortical Bone Screws With 6mm

Shank


A35-06020 Cortical - 60/20

A35-07020 Cortical - 70/20

A35-08030 Cortical - 80/30

A35-09040 Cortical - 90/40

Self-Drilling, Self-Tapping Bone Screws


SD60-15050 Cortical - 150/50

SD60-18060 Cortical - 180/60

SD60-20070 Cortical - 200/70

SD60-25080 Cortical - 250/80

SD50-12030 Cortical - 120/30

SD50-15050 Cortical - 150/50

SD50-18050 Cortical - 180/50

SD50-20080 Cortical - 200/80

SD50-25050 Cortical - 250/50

SD50-25080 Cortical - 250/80

6/5mm Tapered Hydroxyapatite Cortical Bone Screws

With 6mm Shank


HAA60-11030 Cortical - 110/30

HAA60-11040 Cortical - 110/40

HAA60-11050 Cortical - 110/50

HAA60-12040 Cortical - 120/40

HAA60-13030 Cortical - 130/30

HAA60-13040 Cortical - 130/40

HAA60-13050 Cortical - 130/50

HAA60-15020 Cortical - 150/20

HAA60-15030 Cortical - 150/30

HAA60-15040 Cortical - 150/40

HAA60-15050 Cortical - 150/50

HAA60-15060 Cortical - 150/60

HAA60-16030 Cortical - 160/30

HAA60-18030 Cortical - 180/30

HAA60-18050 Cortical - 180/50

HAA60-18060 Cortical - 180/60

HAA60-20030 Cortical - 200/30

HAA60-20040 Cortical - 200/40

HAA60-20050 Cortical - 200/50

HAA60-20060 Cortical - 200/60

HAA60-20080 Cortical - 200/80

HAA60-22050 Cortical - 220/50

HAA60-22060 Cortical - 220/60

HAA60-25030 Cortical - 250/30

HAA60-25040 Cortical - 250/40

HAA60-25050 Cortical - 250/50

HAA60-25060 Cortical - 250/60

HAA60-30060 Cortical - 300/60

Product Information (Continued)

28

6/5mm Tapered Hydroxyapatite Cancellous Bone

Screws With 6mm Shank


HAB60-10030 Cancellous - 100/30












29

Further Information

This brochure describes the surgical technique used by James

V. Nepola, M.D. Biomet Trauma, as the manufacturer of this

device, does not practice medicine and does not recommend

this product or any surgical technique for use on any individual

patient. The surgeon who performs any implant procedure is

responsible for determining the appropriate product(s) and

utilizing the appropriate technique(s) for said implantation in

each individual patient.

For further information, please contact the Customer

Service Department at:

Biomet Trauma

56 East Bell Drive

P.O. Box 587

Warsaw, Indiana 46581-0587

800.348.9500 x 1501

www.biomet.com

30

Notes:

31

Notes:

32

Notes:

©2013 Biomet Orthopedics • Form No. BMET0349.0 • REV011513

All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated.

This material is intended for the sole use and benefit of the Biomet sales force and health care professionals. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet.

For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet’s website.

Responsible ManufacturerBiomet, Inc. P.O. Box 58756 E. Bell DriveWarsaw, Indiana 46581-0587 USA

www.biomet.com

Rx only.

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