# Gramercy Extremity Orthopedics, LLC

- Location (FDA's records): Richardson, TX
- FDA decisions: 5 (2019–2021): 5 510(k) clearances
- Product codes: HRS (3), HWC (1), JDR (1)
- 510(k) review time since 2016: median 56 days, against 87 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 2 (1 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
- Vilex, LLC: 2 (https://510kreport.com/company/vilex)
- Gramercy Extremity Orthopeidics, LLC: 1 (https://510kreport.com/company/gramercy-extremity-orthopeidics)
- Stryker Trauma AG: 1 (https://510kreport.com/company/stryker-trauma)
- Paragon 28, Inc.: 1 (https://510kreport.com/company/paragon-28)
- Vilex IN Tennessee, Inc.: 1 (https://510kreport.com/company/vilex-in-tennessee)
- In2bones USA, LLC: 1 (https://510kreport.com/company/in2bones-usa)

## Firms that cite its devices most
- Trax Surgical: 1 (https://510kreport.com/company/trax-surgical)

## Its most-cited devices
- K200108: GEO 1st MTP Joint Arthrodesis Plating System (2020), cited by 1
- K202817: GEO Bone Screw System (2020), cited by 1

## Recent decisions
- K212334: GEO Extremity and Ankle Plating System (Sep 21, 2021)
- K210534: GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System (Mar 26, 2021)
- K202817: GEO Bone Screw System (Oct 22, 2020)
- K200108: GEO 1st MTP Joint Arthrodesis Plating System (Mar 26, 2020)
- K182212: Geo Staple System (Jan 11, 2019)

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