DEPUY SYNTHES CONTINUOUS COMPRESSION …...Not all Products may currently be available in all...
Transcript of DEPUY SYNTHES CONTINUOUS COMPRESSION …...Not all Products may currently be available in all...
DEPUY SYNTHES CONTINUOUS COMPRESSION IMPLANTSDesigned to provide continuous, active compression throughout the healing processApproved by the AOTK
Ease of Use
Enhanced Implant Design
• Pre-sterilized disposable system includes instrumentation to
enhance operating room efficiencies
• Implants are pre-loaded to save time and hassle in the OR and facilitate
easy, precise placement of the implantInsertion Tool
Depth Gauge
Drilling Templates
SPEED™ Implant
SPEEDTITAN™ Implant
BME ELITE® Implant
Extra wide bridge
Retains compression after repetitive loading
Barbed legs provide secure fixation
High strength, stiffness and rotational stability for high-load applications
The BME ELITE® Continuous Compression Implants (CCIs) were compared to the following constructs: locking titanium
midfoot compression plates, with and without 4.0mm lag screws, and crossing 4.0mm screws. These fixation combinations
are commonly used in various arthrodesis sites. Compression measurements were taken using Tekscan® pressure maps
placed between bicortical Sawbone® blocks. Measurements were taken before and after repetitive loading of 100 cycles
at 2mm displacement.
Constructs using the BME ELITE Implants provided significantly more compression than a locking titanium midfoot
compression plate with and without a 4.0mm lag screw and crossing 4.0mm lag screws.
Continuous Active Compression
Compression Comparison (N)
0
20
40
60
80
100
120
140
160
180
BME ELITE Implant
TR-110-03-16188
SPEEDTITAN Implant
TR-110-03-16188
SPEED Implant
TR-03-120-1430
Two BME ELITE Implants @ 90˚
Plate with Screw
Crossing Screws
P
RE-C
YC
LIN
G
PO
ST-C
YC
LIN
G
TEST SETUP LAPIDUS PROCEDURE TEST RESULTS*
Compression Heat Map Test #: TR-132-03-15131
*Bench Test results may not necessarily be indicative of clinical performance
SPEED CONTINUOUS COMPRESSION IMPLANT
IMPLANT KIT BRIDGE* LEGS* Wire Size*
Drill Kit*
SE-0907 09 07 1.5x1.5 DK-200
SE-0910 09 10 1.5x1.5 DK-200
SE-1110 11 10 1.5x1.5 DK-200
SE-111513 11 15/13 1.5x1.5 DK-200
SE-1310 13 10 1.5x1.5 DK-200
SE-131513 13 15/13 1.5x1.5 DK-200
SE-1512 15 12 1.5x1.5 DK-200
SE-1515 15 15 2x2 DK-265
SE-1815 18 15 2x2 DK-265
SE-1818 18 18/15 2x2 DK-265
SE-1818 18 18 2x2 DK-265
SE-2015 20 15 2x2 DK-265
SE-2020 20 20 2x2 DK-265
SE-2520 25 20 2x2 DK-265
CORRESPONDING DRILL KIT
PARTNUMBER
DRILLBIT SIZE
DRILL GUIDE
HANDLE
LOCATORPINS
TAMP
DK-200 2.00mm Included Included Included
DK-265 2.65mm Included Included Included
ANCILLARY TOOLSPARTNUMBER
DRILL BIT SIZE
SG-1 Continuous Compression Implant Sizing Guide
SPEEDTITAN CONTINUOUS COMPRESSION IMPLANT IMPLANT KIT BRIDGE A* LEGS B*
SE-1515TI 15 15
SE-1815TI 18 15
SE-181815TI 18 18/15
SE-1818TI 18 18
SE-2015TI 20 15
SE-2020TI 20 20
SE-2520TI 25 20
CORRESPONDING DRILL KIT
PARTNUMBER
DRILLBIT SIZE
DRILL GUIDE
HANDLE
LOCATORPINS
TAMP
DK-265-S 2.65mm Included Included Included
ANCILLARY TOOLSPARTNUMBER
DRILLBIT SIZE
SG-1 Continuous Compression Implant Sizing Guide
BME ELITE CONTINUOUS COMPRESSION IMPLANT
IMPLANT KIT BRIDGE* LEGS*NO. of LEGS
MAX. CLOSURE*
EL-1515S2 15 15 2 9.1
EL-1818S2 18 18 2 10.4
EL-2020S2 20 20 2 9.5
EL-2520S4 25 20 4 7.1
EL-3020S4 30 20 4 7.6
CORRESPONDING DRILL/TEMPLATE KITS
PART NUMBER
DRILL BIT SIZE
DRILLING TEMPLATES
LOCATOR PINS
TAMP K-WIRES
DK-300 3.0mm – 4xLP-300 EL-TAMP 0.062 in.
EL-DTS –15, 18, 20,
25, 30– – –
Wide BridgeLow Profile
Narrow Legs
2-Leg Configuration
5.51.5
2.5
Wide BridgeLow Profile
Narrow Legs
4-Leg Configuration
5.5
1.5
2.5
ALL SIZES IN MILLIMETERS
EL-1515S2 EL-1818S2 EL-2020S2 EL-2520S4 EL-3020S4
1.85* Low Profile
Wide Bridge3.5*
1.8*
Wide Bridge
*Sizes in millimeters
*Sizes in millimeters
*Sizes in millimeters
Standard Size Implant
ideal for a variety of procedures in the forefoot
Akin Osteotomies
Designed with a sloped-bridge that conforms to the sloping surfaces of the metaphyseal anatomy
Chevron Osteotomies
Three-legged design provides stable fixation and allows for medial or dorsal placement
Calcaneal Slide Osteotomies
Offset design with a range of offset lengths
Perform incision and bone resections and address soft
tissue contractures as necessary
Large Size Implant
A wider, low-profile bridge for higher strength and compression required for midfoot applications
Extra-large Size Implant
High strength, stiffness, and rotational stability for high-load applications in the midfoot and hindfoot
steotomies
ge
SPEE
DTI
TAN
IMPL
AN
T
SPEED IMPLANT SPEEDARC IMPLANT
SPEEDTRIA
D IM
PLAN
T
BME ELITE IM
PLANT
HAMMERLOCK® 2 IMPLANT
SPEEDSH
IFT
IMPL
AN
T
L
Afr
Various StrengthsDePuy Synthes offers one of the most comprehensive
range of CCIs with proper sizes and strengths for
forefoot, midfoot and hindfoot procedures.
Standard Size Implant
ideal for a variety of procedures in the forefoot
Akin Osteotomies
Designed with a sloped-bridge that conforms to the sloping surfaces of the metaphyseal anatomy
Chevron Osteotomies
Three-legged design provides stable fixation and allows for medial or dorsal placement
Calcaneal Slide Osteotomies
Offset design with a range of offset lengths
Perform incision and bone resections and address soft
tissue contractures as necessary
Large Size Implant
A wider, low-profile bridge for higher strength and compression required for midfoot applications
Extra-large Size Implant
High strength, stiffness, and rotational stability for high-load applications in the midfoot and hindfoot
steotomies
ge
SPEE
DTI
TAN
IMPL
AN
T
SPEED IMPLANT SPEEDARC IMPLANT
SPEEDTRIA
D IM
PLAN
T
BME ELITE IM
PLANT
HAMMERLOCK® 2 IMPLANT
SPEEDSH
IFT
IMPL
AN
T
L
Afr
Procedure Specific Shapes
DePuy Synthes is also the first company to offer
a range of CCIs designed in distinctive shapes
to support a variety of specialized elective
foot procedures.
ANCILLARY TOOLSPART NUMBER NAME
HSPL01 HAMMERSPLINT™
CORRESPONDING DRILL KITPART NUMBER DRILL BIT SIZE
DK-H2 2.10mm
SPEEDARC™ CONTINUOUS COMPRESSION IMPLANT
IMPLANT KIT BRIDGE* LEGS* WIRESIZE*
SE-091210A 9 12/10 1.3x1.5
SE-111210A 11 12/10 1.3x1.5
SE-111512A 11 15/12 1.3x1.5
CORRESPONDING DRILL KIT
PARTNUMBER
DRILLBIT SIZE
DRILL GUIDE
HANDLE
LOCATORPINS
TAMP
DK-200 2.00mm Included Included Included
ANCILLARY TOOLSPARTNUMBER
DESCRIPTION
SG-3 SPEEDARC™ Implant Sizing Guide
SPEEDTRIAD™ CONTINUOUS COMPRESSION IMPLANT
IMPLANT KIT BRIDGE* LEGS* BRIDGEWIDTH* DISTAL LEGS
SE-181508TRC 18 15 8 CENTERED
SE-181508TRL 18 15 8 LEFT OFFSET
SE-181508TRR 18 15 8 RIGHT OFFSET
SE-201508TRC 20 15 8 CENTERED
SE-201508TRL 20 15 8 LEFT OFFSET
SE-201508TRR 20 15 8 RIGHT OFFSET
CORRESPONDING DRILL KIT
PARTNUMBER
DRILLBIT SIZE
DRILL GUIDE
HANDLE
LOCATORPINS
TAMP
DK-200T 2.0mm Included Included Included
ANCILLARY TOOLSPART NUMBER DESCRIPTION
SG-2 SPEEDTRIAD™ Sizing Guide
SPEEDSHIFT™ CONTINUOUS COMPRESSION IMPLANT
IMPLANT KIT BRIDGE* LEGS* OFFSET* WIRESIZE*
SE-1520-06 15 20 6 2x2
SE-1520-08 15 20 8 2x2
SE-1520-10 15 20 10 2x2
SE-2020-04 20 20 4 2x2
SE-2020-06 20 20 6 2x2
SE-2020-08 20 20 8 2x2
SE-2020-10 20 20 10 2x2
SE-2020-12 20 20 12 2x2
CORRESPONDING DRILL KIT
PARTNUMBER
DRILLBIT SIZE
DRILL GUIDE
HANDLE
LOCATORPINS
TAMP
DK-265-S 2.65mm Included Included Included
ANCILLARY TOOLSPART NUMBER DESCRIPTION
SG-1 Continuous Compression Implant Sizing Guide
OT-1 Offset Sizing Tool
HAMMERLOCK® 2 CONTINUOUS COMPRESSION IMPLANT
ANGLE SIZE CAT. NO A* B* C* D* E* F*
0° SMALL HL2S 17.2 5.2 12.0 5.6 5.4 4.3
0° MEDIUM HL2M 20.2 5.2 15.0 6.0 5.4 5.0
0° LARGE HL2L 22.0 7.0 15.0 6.0 7.0 5.0
10° SMALL HL2SA 17.2 5.2 12.0 5.6 5.4 4.3
10° MEDIUM HL2MA 20.2 5.2 15.0 6.0 5.4 5.0
10° LARGE HL2LA 22.0 7.0 15.0 6.0 7.0 5.0
Shape when activated
* All sizes in millimeters describing implants in activated states. X-ray Template A125-005 may be used to determine implant size.
*Sizes in millimeters
*Sizes in millimeters
*Sizes in millimeters
RIGHT OFFSET CENTER OFFSET LEFT OFFSET
© DePuy Sythes 2018. All rights reserved.
Third party trademarks used herein are the trademarks of their respective owners DSUS/TRM/0417/1426(2) 3/18
Manufactured or Distributed by:
Synthes USA, LLC1101 Synthes AvenueMonument, CO 80132
Note: For recognized manufacturer, refer to the product label
www.depuysynthes.com
Limited Warranty and Disclaimer: DePuy Synthes Products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, includingwarranties of merchantability or fitness, are hereby disclaimed. Please also refer to the package insert(s) or other labeling associated with the devices identified in this sales document for additional information.
CAUTION: Federal Law restricts these devices to sale by or on the order of a physician. Some devices listed in this sales aid may not have been licensed in accordance with Canadian law and may not be for sale in Canada.
Please contact your sales consultant for items approved for sale in Canada.
Not all Products may currently be available in all markets.
BioMedical Enterprises, Inc.14785 Omicron Dr., Suite 205San Antonio, TX 78245
SPEED, SPEEDARC, SPEEDTITAN, SPEEDSHIFT, BME ELITE Continuous Compression Implants Indications: • Fracture and osteotomy fixation and joint arthrodesis of hand and foot. • Fixation of proximal tibial metaphysis osteotomy. • Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located
in long bones such as femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle; and in flat bone such as pelvis, scapula.
Contraindications:• Comminuted bone surface that would militate against staple placement. • Pathologic conditions of bone such as osteopenia that would impair the ability to securely fix the implant. • Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate test should be made prior to implantation.
SPEEDTRIAD Continuous Compression Implants Indications:• Fracture and osteotomy fixation and joint arthrodesis of hand and foot.
Contraindications:• Comminuted bone surface that would militate against staple placement. • Pathologic conditions of bone such as osteopenia that would impair the ability to securely fix the implant. • Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate test should be made prior to implantation.
HAMMERLOCK 2 Continuous Compression Implants Indications:Small bone reconstruction and fusion such as in the phalanges of the fingers and toes Contraindications:• Pathologic conditions of bone such as osteopenia that would impair the ability to securely fix the implant.• Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate test should be made prior to implantation.
Anatomic ReductionFracture reduction and fixation to restore anatomical relationships.
Stable FixationFracture fixation providing absolute or relative stability, as required by the patient, the injury, and the personality of the fracture.
Early, Active Mobilization Early and safe mobilization and rehabilitation of
the injured part and the patient as a whole.
Preservation of Blood Supply Preservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.
AO PrinciplesIn 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.1,2
1Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991.2Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.