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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / March 2026 / K260361

510(k) cleared

Treace Medical Concepts (TMC) Screw Fixation System

Treace Medical Concepts, Inc. · Mar 6, 2026 · K260361

FDA cleared the Treace Medical Concepts (TMC) Screw Fixation System from Treace Medical Concepts, Inc. on Mar 6, 2026 under K260361, a special 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 4, 2026. The decision came 30 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: K262963 (TMC Implant Fixation System).

Questions & Answers

What did FDA clear under K260361?

K260361 is the FDA 510(k) for Treace Medical Concepts (TMC) Screw Fixation System, submitted by Treace Medical Concepts, Inc.. FDA's decision date was Mar 6, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the Treace Medical Concepts (TMC) Screw Fixation System?

Treace Medical Concepts, Inc., based in Ponte Vedra, FL, is the applicant of record for K260361.

How long did the K260361 review take?

FDA received the submission on Feb 4, 2026 and issued its decision on Mar 6, 2026, 30 days later.

← All decisions in March 2026

Sources