Treace Medical Concepts (TMC) Implant Fixation System— 510(k) K251135

Name: FDA 510(k) clearance K251135
Creator: U.S. Food and Drug Administration
Published: 2025-08-21

Substantially Equivalent

Treace Medical Concepts

FDA 510(k) clearance K251135 for Treace Medical Concepts (TMC) Implant Fixation System, Substantially Equivalent on 2025-08-21. Applicant: Treace Medical Concepts. Device class: 2.

Clearance details

Applicant: Treace Medical Concepts
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-04-14
Decision date: 2025-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Ponte Vedra, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Treace Medical Concepts

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K243658 — TMC Compression Implant System2024-12-26
K242415 — TMC Compression Implant System2024-09-06
K232387 — Treace Medical Concepts (TMC) Compression Implant System2023-08-28
K222645 — Treace Medical Concepts (TMC) Implant Fixation System2022-11-21

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.