product information - medshape · 3000-00-141414 dynaclip, 14 mm x 14 mm x 14 mm 3000-00-181818...

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PRODUCT INFORMATION DYNAMIC STABILITY WITH NEXT-GENERATION STRENGTH For further product information or to arrange a product demonstration, please contact your local MedShape representative or call Customer Service at 877-343-7016. You can also visit www.medshape.com. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. ©MedShape, Inc., 2018. All rights reserved. Printed in the USA. Pat: http://www.medshape.com/patents.html Other U.S. and International Patents Pending. MK-10168 Rev 00. Issued 10/2018. DynaClip is a trademark of MedShape, Inc. All other trademarks are trademarks of their respective owners or holders. MedShape, Inc. 1575 Northside Drive, NW Suite 440 Atlanta, GA 30318 T: 877-343-7016 F: 877-343-7017 DYNACLIP IMPLANTS & SINGLE USE INSTRUMENTS Part No. Description 3000-00-080808 DynaClip, 8 mm x 8 mm x 8 mm 3000-00-101010 DynaClip, 10 mm x 10 mm x 10 mm 3000-00-121212 DynaClip, 12 mm x 12 mm x 12 mm 3000-00-141414 DynaClip, 14 mm x 14 mm x 14 mm 3000-00-181818 DynaClip, 18 mm x 18 mm x 18 mm 3000-00-182020 DynaClip, 18 mm x 20 mm x 20 mm 3000-00-201818 DynaClip, 20 mm x 18 mm x 18 mm 3000-00-202222 DynaClip, 20 mm x 22 mm x 22 mm 3000-00-262020 DynaClip, 26 mm x 20 mm x 20 mm 3000-01-000 Universal Procedure Pack, Sterile 2 4 3 1 5 - Universal Drill Guide • Serves as both implant sizer AND drill guide • Compatible with ALL size offerings by using adjustable Slide • Ergonomic, low-profile handle to maximize visibility of fusion site. EFFICIENT INSTRUMENTATION Universal Procedure Pack Disposable, single-use, sterile kit that contains ALL instruments needed to prepare the fusion site. No need to open multiple packs! 1 - 2 mm Drill 2 - 3 mm Drill 3 - 2 mm Locator Pins 4 - 3 mm Locator Pins 5 Drill Sleeves Body Slide

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Page 1: PRODUCT INFORMATION - MedShape · 3000-00-141414 DynaClip, 14 mm x 14 mm x 14 mm 3000-00-181818 DynaClip, 18 mm x 18 mm x 18 mm 3000-00-182020 DynaClip, 18 mm x 20 mm x 20 mm 3000-00-201818

PRODUCT INFORMATION

DYNAMIC STABILITY WITH NEXT-GENERATION

STRENGTH

For further product information or to arrange a product demonstration, please contact your local

MedShape representative or call Customer Service at 877-343-7016.

You can also visit www.medshape.com.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.©MedShape, Inc., 2018. All rights reserved. Printed in the USA. Pat: http://www.medshape.com/patents.html Other U.S. and International Patents Pending. MK-10168 Rev 00. Issued 10/2018. DynaClip is a trademark of MedShape, Inc. All other trademarks are trademarks of their respective owners or holders.

MedShape, Inc.1575 Northside Drive, NWSuite 440Atlanta, GA 30318T: 877-343-7016F: 877-343-7017

DYNACLIP IMPLANTS & SINGLE USE INSTRUMENTS

Part No. Description

3000-00-080808 DynaClip, 8 mm x 8 mm x 8 mm

3000-00-101010 DynaClip, 10 mm x 10 mm x 10 mm

3000-00-121212 DynaClip, 12 mm x 12 mm x 12 mm

3000-00-141414 DynaClip, 14 mm x 14 mm x 14 mm

3000-00-181818 DynaClip, 18 mm x 18 mm x 18 mm

3000-00-182020 DynaClip, 18 mm x 20 mm x 20 mm

3000-00-201818 DynaClip, 20 mm x 18 mm x 18 mm

3000-00-202222 DynaClip, 20 mm x 22 mm x 22 mm

3000-00-262020 DynaClip, 26 mm x 20 mm x 20 mm

3000-01-000 Universal Procedure Pack, Sterile

24

3

1

5 - Universal Drill Guide

• Serves as both implant sizer AND drill guide

• Compatible with ALL size offerings by using adjustable Slide

• Ergonomic, low-profile handle to maximize visibility of fusion site.

EFFICIENT INSTRUMENTATION

Universal Procedure PackDisposable, single-use, sterile kit that contains ALL instruments needed to prepare the fusion site.No need to open multiple packs!

1 - 2 mm Drill2 - 3 mm Drill3 - 2 mm Locator Pins4 - 3 mm Locator Pins

5

Drill Sleeves

Body

Slide

Page 2: PRODUCT INFORMATION - MedShape · 3000-00-141414 DynaClip, 14 mm x 14 mm x 14 mm 3000-00-181818 DynaClip, 18 mm x 18 mm x 18 mm 3000-00-182020 DynaClip, 18 mm x 20 mm x 20 mm 3000-00-201818

THE PROOF IS IN THE SCIENCE

DESIGN RATIONALE

Built-in tamp

Low profile to ensure visibility of fusion site

Strike surface

DYNACLIP INSERTER

The DynaClip’s versatile design and numerous size offerings allow for its use in a variety of procedures including:

1. Akin Osteotomy2. Chevron Osteotomy3. Lapidus Fusion4. Talonavicular Fusion5. Calcaneocuboid Fusion6. Tarsometatarsal Fusion

NEXT-GENERATION STRENGTHDESIGNED TO CLIP THE COMPETITION

Competitor staples have either a thin bridge or broad bridge with thin legs which place all stresses on the staple corner, increasing the likelihood for implant failure.

Low-profile continuous cross section along entire bridge

Broad bridge design provides additional stiffness and durability

24o of bridge curvature to maximize compression

Superelastic NiTiNOL construction allows for dynamic post-operative compression

Variable length teeth cut into legs for improved pullout resistance

Testing performed per ASTM F564. Values represent mean +/- standard deviation, *p<0.05 vs. FuseForce of same size.

When subjected to static 4-point bending, the DynaClip is at least 66% stronger compared with a competitor NiTiNOL staple across the range of size offerings.1

Superior Bending Strength

Dependable Durability

Testing performed per ASTM F564. Values represent mean +/- standard deviation, *p<0.05 vs. FuseForce of same size.

When subjected to cyclic 4-point bending at the same force, the Dyna-Clip is able to resist implant failure for 6X more loading-unloading cycles compared with a competitor NiTiNOL staple across the range os size offerings.1

• Pre-loaded on disposable inserter• Fast, Easy Deployment. No Twisting!

Strains concentrated at corner where bridge transitions to leg

Competitor Staples

Finite Element Analysis under 3-Point Bending

1 Data on File, MedShape, 2018.

DynaClip™

Minimaldeformation in legs

Strains distributed uniformly through bridge

Thanks to a unique manufacturing method, the DynaClip’s patent-pending design evenly distributes stresses across the bridge, thereby ensuring reliable, long term stability post-surgery.