Cleared Traditional

Treace Medical Concepts (TMC) Snap-Off Screw System

K183363 · Treace Medical Concepts, Inc. · Orthopedic
Jun 2019
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K183363 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Snap-Off Screw 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 June 13, 2019, 191 days after receiving the submission on December 4, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K183363 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2018
Decision Date June 13, 2019
Days to Decision 191 days
Submission Type Traditional
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

Similar Devices — HWC Screw, Fixation, Bone

All 1049
Treace Medical Concepts (TMC) Screw Fixation System
K260361 · Treace Medical Concepts, Inc. · Mar 2026
Tyber Medical Trauma Screw
K252901 · Tyber Medical, LLC · Dec 2025
Ultra? Compression Screw System
K251555 · Pace Surgical · Nov 2025
Eleganz IM Threaded Nail System (IM Threaded Nail System)
K252312 · Dev4 · Oct 2025
MetaFore Small Screw System
K250536 · Extremity Medical, LLC · Oct 2025
Cannulated Screw and Kirschner (K wire) System
K252758 · Orthonovis, Inc. · Oct 2025