# MedShape, Inc.

- Location (FDA's records): Atlanta, GA
- FDA decisions: 17 (2012–2026): 17 510(k) clearances
- Product codes: HWC (7), JDR (3), MBI (3), HSB (3), HTN (1)
- 510(k) review time since 2016: median 146 days, against 108 for FDA's reviews in the same codes and years (4 of 11 faster)
- Predicates its devices cite: 40 (18 its own); citations of its devices by later devices: 29 (18 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medshape Solutions: 8 (https://510kreport.com/company/medshape-solutions)
- Arthrex, Inc.: 4 (https://510kreport.com/company/arthrex)
- Trilliant Surgical, Ltd.: 2 (https://510kreport.com/company/trilliant-surgical)
- Tyber Medical, LLC: 2 (https://510kreport.com/company/tyber-medical)
- Biomedical Enterprises, Inc.: 2 (https://510kreport.com/company/biomedical-enterprises)
- Solana Surgical, LLC: 1 (https://510kreport.com/company/solana-surgical)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)

## Firms that cite its devices most
- Paragon 28, Inc.: 2 (https://510kreport.com/company/paragon-28)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Signus Medizintechnik GmbH: 1 (https://510kreport.com/company/signus-medizintechnik)
- Restor3D: 1 (https://510kreport.com/company/restor3d)
- University of Utah, Department of Orthopaedics: 1 (https://510kreport.com/company/university-of-utah-department-of-orthopaedics)
- Satori Orthopaedics, Inc.: 1 (https://510kreport.com/company/satori-orthopaedics)
- Nuvasive Specialized Orthopedics, Inc.: 1 (https://510kreport.com/company/nuvasive-specialized-orthopedics)
- Flower Orthopedics Corporation Dba Conventus Flower Ortho: 1 (https://510kreport.com/company/flower-orthopedics-dba-conventus-flower-ortho)

## Its most-cited devices
- K171376: DynaNail TTC Fusion System (2017), cited by 7
- K203595: DynaFuse Fixation System (2022), cited by 4
- K203381: Dynanail Mini Hybrid (2021), cited by 3
- K113828: Dynanail Ankle Arthrodesis Nail (2012), cited by 3
- K182677: DynaNail Mini (2019), cited by 3
- K193305: DynaClip Bone Staple (2020), cited by 2

## Recent decisions
- K260995: DynaNail Helix® Fixation System (Sep 23, 2026)
- K254110: DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (Mar 18, 2026)
- K250628: DynaNail TTC Fusion System (Sep 12, 2025)
- K240530: DynaNail Mini Tapered Hybrid (Mar 21, 2024)
- K220812: DynaClip® Bone Staple (Aug 19, 2022)
- K203595: DynaFuse Fixation System (Jan 4, 2022)
- K203381: Dynanail Mini Hybrid (Jan 15, 2021)
- K193305: DynaClip Bone Staple (Apr 23, 2020)

Source page: https://510kreport.com/company/medshape