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The Tracker / September 2026 / K262963

510(k) cleared

TMC Implant Fixation System

Treace Medical Concepts, Inc. · Sep 15, 2026 · K262963

FDA cleared the TMC Implant Fixation System from Treace Medical Concepts, Inc. on Sep 15, 2026 under K262963, a special 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 25, 2026. The decision came 21 days later, inside the 90 FDA-day goal for a 510(k).

Treace Medical Concepts, Inc. has one other decision in the tracker over the last 12 months: K260361 (Treace Medical Concepts (TMC) Screw Fixation System).

Questions & Answers

What did FDA clear under K262963?

K262963 is the FDA 510(k) for TMC Implant Fixation System, submitted by Treace Medical Concepts, Inc.. FDA's decision date was Sep 15, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the TMC Implant Fixation System?

Treace Medical Concepts, Inc., based in Ponte Vedra, FL, is the applicant of record for K262963.

How long did the K262963 review take?

FDA received the submission on Aug 25, 2026 and issued its decision on Sep 15, 2026, 21 days later.

← All decisions in September 2026

Sources