Treace Medical Concepts (TMC) Implant Fixation System

Treace Medical Concepts (TMC) Implant Fixation System is an FDA 510(k)-cleared medical device (K222645) manufactured by Treace Medical Concepts. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 2022. Regulation: 8.