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BME ELITE ® CONTINUOUS COMPRESSION IMPLANT Product Overview

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Page 1: BME ELITE CONTINUOUS COMPRESSION IMPLANTsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes... · 120 100 80 60 40 20 0 One 4-Legged BME ELITE One Plate Implant Locking Ti Midfoot

BME ELITE® CONTINUOUS COMPRESSION IMPLANTProduct Overview

Page 2: BME ELITE CONTINUOUS COMPRESSION IMPLANTsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes... · 120 100 80 60 40 20 0 One 4-Legged BME ELITE One Plate Implant Locking Ti Midfoot

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One 4-Legged BME ELITE One Plate Implant Locking Ti Midfoot EL-2520S4 Compression Plate

The BME ELITE® Continuous Compression Implants 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.

CONSTRUCT RIGIDITYConstruct rigidity, shown by the amount of force required to displace the constructs 2mm, was tested using a four-point bending apparatus. Measurements were taken for the first and 100th cycle of repetitive loading.

BME ELITE 4-leg Implants were tested against a leading locking titanium midfoot plate. The graph to the right shows the results.

TORSIONAL STABILITYTorsional stability is the amount of force required to torque the constructs 15 degrees. Fixation combinations simulated arthrodesis of the talonavicular joint. Measurements were taken for the first and 100th cycle of repetitive loading.

Two BME ELITE 4-leg Implants in parallel were tested against a locking titanium midfoot compression plate with and without a 4.0mm lag screw. The graph to the right shows the results.

Continuous Active Compression

Compression Before and After Repetitive Loading (N)‡

(100 Cycles at 2mm Displacement)** Before BeforeAfter After

Construct Rigidity at 1st and 100th Cycle (N)‡(100 Cycles at 2mm Displacement)**

1st Cycle 1st Cycle100th Cycle 100th Cycle

350300250200150100

500

Two BME Elite Plate with Screw Plate Implants - Parallel Locking Ti Midfoot Locking Ti Midfoot EL-2520S4 Compression Plate Compression Plate w/ 4.0mm Lag Screw

1ST TMT

Torsional Stability (Torque) at 1st and 100th Cycle (N∙cm)

(100 Cycles at 15-degrees Displacement)**

1st Cycle 1st Cycle100th Cycle 100th Cycle

Extra wide bridge

Retains compression after repetitive loading

Barbed legs provide secure fixation

High strength, stiffness and rotational stability for high-load applications

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*

160140120100806040200

Two BME ELITE Plate Crossing Screws Implants - Parallel Locking Ti Midfoot 4.0mm Lag Screw EL-2520S4 Compression Plate

TALONAVICULAR & CALCANEOCUBOID

1

160140120100806040200

One BME ELITE Implant Plate EL-2020S2 Locking Ti Midfoot Compression Plate

LESSER TMT160140120100806040200

Two BME ELITE Plate with Screw Crossing Screws Implants @ 90˚ Locking Ti Midfoot 4.0mm Lag Screws EL- 252054 & EL-1818S2 Compression Plate w/ 4.0mm Lag Screw

1

1ST TMT

**VER-132-09‡IN=0.225 Pounds-force

Compression Heat Map Test #: TR-132-03-15131

Pre-sterilized, fully disposable system. Ready for use - no heating, freezing or spreading required.

*Bench Test results may not necessarily be indicative of clinical performance**VER-132-09‡IN=0.225 Pounds-force

Page 3: BME ELITE CONTINUOUS COMPRESSION IMPLANTsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes... · 120 100 80 60 40 20 0 One 4-Legged BME ELITE One Plate Implant Locking Ti Midfoot

© DePuy Sythes 2017. All rights reserved. DSUS/TRM/0816/1001(1) 5/17

Manufactured or Distributed by:

Synthes USA, LLC1101 Synthes AvenueMonument, CO 80132

www.depuysynthes.com

**SIZES IN MILLIMETERS

BME ELITE CONTINUOUS COMPRESSION IMPLANTS 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 KITSPART 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 Bridge

Wide Bridge

Low Profile

Low Profile

Narrow Legs

Narrow Legs

2-Leg Configuration

4-Leg Configuration

5.5

5.5

1.5

1.5

2.5

2.5

ALL SIZES IN MILLIMETERS

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, including warranties 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.

Third party trademarks used herein are the trademarks of their respective owners

E

C E

D

A

A B

B

C

E

D

0.062 in. K-wires (4)

3.0mm Drill Bit

Depth Gauge

Tamp

Pull Pins (4)

DK-300 Drill Kit

BioMedical Enterprises, Inc.14785 Omicron Dr., Suite 205San Antonio, TX 78245