# Treace Medical Concepts, Inc.

- Location (FDA's records): Ponte Vedra, FL
- FDA decisions: 21 (2015–2026): 21 510(k) clearances
- Names in FDA's records: Treace Medical Concepts, Inc. (16); Treace Medical Concepts (5)
- Product codes: HRS (11), HWC (6), JDR (4)
- 510(k) review time since 2016: median 30 days, against 93 for FDA's reviews in the same codes and years (16 of 20 faster)
- Predicates its devices cite: 46 (24 its own); citations of its devices by later devices: 28 (24 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
- Wrightmedicaltechnologyinc: 5 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Crossroads Extremity Systems, LLC: 2 (https://510kreport.com/company/crossroads-extremity-systems)
- Orthohelix Surgical Designs, Inc.: 2 (https://510kreport.com/company/orthohelix-surgical-designs)
- Z-Medical GmbH & Co. KG: 2 (https://510kreport.com/company/z-medical)
- I.T.S. GmbH: 1 (https://510kreport.com/company/its)
- Apogee Orthosolutions: 1 (https://510kreport.com/company/apogee-orthosolutions)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Wright Medical Corp.: 1 (https://510kreport.com/company/wright-medical)

## Firms that cite its devices most
- In2bones USA, LLC: 1 (https://510kreport.com/company/in2bones-usa)
- Sky Surgical, LLC: 1 (https://510kreport.com/company/sky-surgical)
- Trax Surgical: 1 (https://510kreport.com/company/trax-surgical)
- Orthocircle Spine D.B.A. OC Medical Devices: 1 (https://510kreport.com/company/orthocircle-spine-dba-oc-medical-devices)

## Its most-cited devices
- K172617: Treace Medical Concepts (TMC) Compression Screw System (2017), cited by 3
- K143717: Treace Medical Concepts (TMC) Plating System (2015), cited by 3
- K153531: Treace Medical Concepts (TMC) Plating System (2016), cited by 2
- K240173: Treace Medical Systems (TMC) Plating System (2024), cited by 2
- K213036: Treace Medical Concepts (TMC) Screw Fixation System (2021), cited by 2
- K222645: Treace Medical Concepts (TMC) Implant Fixation System (2022), cited by 2

## Recent decisions
- K262963: TMC Implant Fixation System (Sep 15, 2026)
- K260361: Treace Medical Concepts (TMC) Screw Fixation System (Mar 6, 2026)
- K251135: Treace Medical Concepts (TMC) Implant Fixation System (Aug 21, 2025)
- K243658: TMC Compression Implant System (Dec 26, 2024)
- K242671: Treace Medical Concepts (TMC) Screw Fixation System (Oct 4, 2024)
- K242415: TMC Compression Implant System (Sep 6, 2024)
- K240173: Treace Medical Systems (TMC) Plating System (Feb 22, 2024)
- K232387: Treace Medical Concepts (TMC) Compression Implant System (Aug 28, 2023)

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