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

Name: FDA 510(k) clearance K222645
Creator: U.S. Food and Drug Administration
Published: 2022-11-21

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. Device class: 2.

Clearance details

Applicant: Treace Medical Concepts
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
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 ↗

Recent devices under product code JDR

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K262451 — Arthrex DynaNite Staples2026-09-01
K261121 — Megalodon Dynamic Compression System2026-08-06
K250712 — Linkt Compression Staple System2025-05-14
K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System2025-04-11
K243742 — Arthrex DynaNite Nitinol Staples2025-01-31

More clearances from Treace Medical Concepts

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K251135 — Treace Medical Concepts (TMC) Implant Fixation System2025-08-21
K243658 — TMC Compression Implant System2024-12-26
K242415 — TMC Compression Implant System2024-09-06
K232387 — Treace Medical Concepts (TMC) Compression Implant System2023-08-28

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.