DynaNail Mini® Fusion System - Product Information | MedShape, Inc.

1. PRODUCT INFORMATION FEATURING PATENTED SUPERELASTIC NiTiNOL TECHNOLOGY

2. IT’S SUPERELASTIC! THE “RUBBER-BAND” EFFECT. The DynaNail Mini features MedShape’s patented and proven superelastic NiTiNOL technology.1,2 The internal NiTiNOL Compressive Element is stretched (1 in below graph) and fxed with screws (2). Post-surgery, the NiTiNOL Element will automatically recover its stretched length due to unloading in response to bone resorption or settling (3), analogous to a very strong rubber band. The DynaNail Mini® Fusion System is designed for use in subtalar fusion and in the fusion of other large bones in the foot and ankle. NiTiNOL Stress Strain 2 1 Unload Stretch “I was initially attracted to the DynaNail Mini due to its excellent post-operative compression, particularly in patients with poor bone quality. From my experience so far, I have found the nail to be easy to use and the results reproducible across my patient population.” Stress Pseudoelastic Recovery 3 0 0 1 2 3 4 5 6 7 – Terrence Philbin, DO Orthopedic Foot & Ankle Columbus, Ohio Strain (%) “As a big believer in the dynamic compression capabilities of NiTiNOL in promoting fusion, I am pleased to add the DynaNail Mini to my arsenal of surgical tools. The DynaNail Mini offers the same benefits of sustained post-operative compression as its predecessor, the DynaNail, but now in a smaller size expanding the use of NiTiNOL to other indications.” NEW! PRE-LOADED ASSEMBLY The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Just connect the Nail Guide to the Mini Targeting Frame and implant! Nail Guide – Kent Ellington, MD OrthoCarolina Foot & Ankle Institute Charlotte, North Carolina Internal NiTiNOL Element 1-Yakacki CM, Gall K, Dirschl DR, Pacaccio DJ. Pseudoelastic intramedullary nailing for tibio-talo-calcaneal arthrodesis. Expert Rev Med Devices 2011; 8(2): 159-66. Nail Outer Body 2-1.Ford SE, Kwon JY, Ellington K. Tibiotalocalcaneal Arthrodesis Utilizing a Titanium Intramedullary Nail With an Internal Pseudoelastic Nitinol Compression Element: A Retrospective Case Series of 33 Patients. J Foot Ankle Surg, 2019. 58(2): 266-272. 3-Data on File, MedShape, 2019.

3. THE SAME MAINTAINED COMPRESSION PERFORMANCE. NOW IN A SMALLER FORM • Offers between 2-4 mm of post-operative compression PLUS intra-operative manual compression Transverse Screw • Provides strong joint stability due to maintained compression • Dual transverse screw fxation to prevent device migration Titanium Outer Nail Body Maintained Active Compression Unlike traditional screws that lose compression within 1 mm of bone resorption, the DynaNail Mini is the ONLY internal device for subtalar fusion procedures that maintains active compression post-surgery in response to bone resorption or settling. The amount of compression maintained varies by the length of the Mini Implant.3 Amount of available post-operative compression by implant length Slotted Calcaneal Screw Hole Internal NiTiNOL Compressive Element Nail Length Compression 60 mm 1.8 mm 70 mm 2.2 mm 80 mm 2.8 mm Transverse Screw 90 mm 3.4 mm 100 mm 4.0 mm Sliding Element WATCH THE COMPRESSIVE ELEMENT IN ACTION 11 Weeks Post-Surgery X-Ray of 70 mm DynaNail Mini implanted in 81 year old female. ** 1 mm 1 mm The distance the NiTiNOL Element recovers can be measured and tracked on x-ray post-surgery. In this case, with a 70mm, the Calcaneal Screw is located 1 mm from proximal end of Nail Outer Body slot indicating the NiTiNOL Element has recovered 1.2 mm of its stretched length with 1 mm of compression remaining. ** Images courtesy of Terrence Philbin, DO (Orthopedic Foot & Ankle, Columbus, OH)

4. Targeting Arm DYNANAIL MINI TARGETING FRAME • Manufactured out of durable carbon-fber PEEK Bone Apposition Sleeve • Rigid, robust construction for accurate targeting and screw placement Manual Compression Wheel • Radiolucent to permit radiographic visualization Lasermarked numbers indicate order of steps Retention Knob DYNANAIL MINI IMPLANTS DYNANAIL MINI SINGLE USE INSTRUMENTS Part No. Description Part No. Description 2600-00-7060 DynaNail Mini, 7 mm x 60 mm 2200-19-0020 Steinmann Pin, 2 mm x 9" 2600-00-7070 DynaNail Mini, 7 mm x 70 mm 2900-16-070 Cannulated Drill, 7.0 mm 2600-00-7080 DynaNail Mini, 7 mm x 80 mm 2900-16-075 Cannulated Drill, 7.5 mm 2600-00-7090 DynaNail Mini, 7 mm x 90 mm 2900-16-080 Cannulated Drill, 8 mm 2600-00-7100 DynaNail Mini, 7 mm x 100 mm 2900-16-085 Cannulated Drill, 8.5 mm 2600-00-8060 DynaNail Mini, 8 mm x 60 mm 2900-03-0400 Transverse Screw Drill, 4 mm 2600-00-8070 DynaNail Mini, 8 mm x 70 mm 2900-04-0380 Stepped Guidewire, 2.4 mm x 380 mm 2600-00-8080 DynaNail Mini, 8 mm x 80 mm 2600-00-8090 DynaNail Mini, 8 mm x 90 mm CHECK OUT THE ENTIRE DYNANAIL® PRODUCT LINE! 2600-00-8100 DynaNail Mini, 8 mm x 100 mm 2600-03-4322 Headless Screw, 4 mm x 22 mm 2600-03-4324 Headless Screw, 4 mm x 24 mm 2600-03-4326 Headless Screw, 4 mm x 26 mm 2600-03-4328 Headless Screw, 4 mm x 28 mm 2600-03-4330 Headless Screw, 4 mm x 30 mm Available in 220, 260, and 300 mm lengths for use in tibiotalocalcaneal (TTC) fusion procedures. 2600-03-4332 Headless Screw, 4 mm x 32 mm 2600-03-4334 Headless Screw, 4 mm x 34 mm 2600-03-4336 Headless Screw, 4 mm x 36 mm 2600-03-4338 Headless Screw, 4 mm x 38 mm MedShape, Inc. 1575 Northside Drive, NW Suite 440 Atlanta, GA 30318 T: 877-343-7016 F: 877-343-7017 2600-03-4340 Headless Screw, 4 mm x 40 mm 2600-05-0000 Endcap 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., 2019. All rights reserved. Printed in the USA. MK-10173 Rev. 00. Issued 09/2019. Pat.: http://www.medshape.com/patents.html. DynaNail is a registered trademark of MedShape, Inc. All other trademarks are trademarks of their respective owners or holders.