# Extremity Medical, LLC

- Location (FDA's records): Parsippany, NJ
- FDA decisions: 28 (2008–2025): 28 510(k) clearances
- Product codes: HWC (16), HRS (6), MBI (2), KTT (2), JWJ (1), KYI (1)
- 510(k) review time since 2016: median 57 days, against 99 for FDA's reviews in the same codes and years (10 of 12 faster)
- Predicates its devices cite: 87 (28 its own); citations of its devices by later devices: 48 (28 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 8 (https://510kreport.com/company/synthes-usa)
- Wrightmedicaltechnologyinc: 8 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Paragon 28, Inc.: 5 (https://510kreport.com/company/paragon-28)
- Jeil Medical Corporation: 4 (https://510kreport.com/company/jeil-medical)
- Orthohelix Surgical Designs, Inc.: 3 (https://510kreport.com/company/orthohelix-surgical-designs)
- Osteomed LP: 3 (https://510kreport.com/company/osteomed)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)

## Firms that cite its devices most
- Nextremity Solutions, Inc.: 3 (https://510kreport.com/company/nextremity-solutions)
- Paragon 28, Inc.: 2 (https://510kreport.com/company/paragon-28)
- Nvision Biomedical Technologies, Inc.: 2 (https://510kreport.com/company/nvision-biomedical-technologies)
- Exremity Medical, LLC: 2 (https://510kreport.com/company/exremity-medical)
- Armis Biopharma, Inc.: 1 (https://510kreport.com/company/armis-biopharma)
- Medartis AG: 1 (https://510kreport.com/company/medartis)
- Restore Surgical, LLC Dba Instratek: 1 (https://510kreport.com/company/restore-surgical-dba-instratek)
- Fusion Orthopedics, LLC: 1 (https://510kreport.com/company/fusion-orthopedics)

## Its most-cited devices
- K133636: Extremity Medical Hammertoe Device (2014), cited by 9
- K082934: Extremity Medical Midfoot Screw System (2009), cited by 5
- K121349: IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer (2012), cited by 5
- K101700: IO Fix Hand, IO Fix Foot, Extremity Medical Screw System (2010), cited by 4
- K081934: Extremity Medical Compression Screw (2008), cited by 4
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System (2017), cited by 4

## Recent decisions
- K250536: MetaFore Small Screw System (Oct 8, 2025)
- K251128: Extremity Medical External Fixation System (May 7, 2025)
- K241563: Extremity Medical External Fixation System (Feb 21, 2025)
- K212297: Omni Foot and Ankle Plating System (Aug 20, 2021)
- K211261: Axis Charcot Fixation System (May 28, 2021)
- K201556: Intraosseous Fixation System (Jul 8, 2020)
- K191525: KinematX Total Wrist Arthroplasty System (Mar 4, 2020)
- K192592: Axis Plating System (Nov 21, 2019)

Source page: https://510kreport.com/company/extremity-medical