Cleared Special

Treace Medical Concepts (TMC) Screw Fixation System

K260361 · Treace Medical Concepts, Inc. · Orthopedic
Mar 2026
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K260361 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Screw Fixation System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Treace Medical Concepts, Inc. (Ponte Vedra, US). The FDA issued a Cleared decision on March 6, 2026, 30 days after receiving the submission on February 4, 2026. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K260361 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2026
Decision Date March 06, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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