Treace Medical Concepts Plating System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183321 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Treace Medical Concepts Plating System is an orthopedic fixation device designed for internal stabilization of bone fractures. It includes anatomically shaped plates (straight, L-shaped, H-shaped, and curved) and screws to provide rigid fixation across complex fracture sites, particularly in the tarsometatarsal joint and revision cases.
This system is supplied as a reusable surgical implant and is intended for use in orthopedic procedures under sterile conditions. Plates and screws are available in diameters of 2.5 mm, 2.7 mm, and 3.0 mm, with screw lengths ranging from 10 mm to 32 mm. The device holds FDA 510(k) clearance (K183321) under the Traditional pathway and is categorized under the Orthopedic advisory committee (OR) for regulatory review.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lapiplasty® Anatomic Biplanar Plate Systems | Treace Medical Concepts, Products - Treace Medical Concepts, Treace Medical Concepts Implant Fixation System - Plating System ..., PDF Treace Medical Concepts Plating System Instructions for Use, Treace Medical Concepts (TMC) Plating System (K221181) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183321 | Class II | Active |
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Manufacturer
- Manufacturer
- Treace Medical Concepts, Inc.
Sources (1)
- FDA 510(k) K183321 24 fields · synced Sep 19, 2026