Treace Medical Concepts (TMC) Implant Fixation System— 510(k) K222645

Substantially Equivalent

Treace Medical Concepts

FDA 510(k) clearance K222645 for Treace Medical Concepts (TMC) Implant Fixation System, Substantially Equivalent on 2022-11-21. Applicant: Treace Medical Concepts.

Clearance details

Applicant: Treace Medical Concepts
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2022-09-01
Decision date: 2022-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ponte Vedra, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.