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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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).

This is the only decision on file for Treace Medical Concepts, Inc. in the last 12 months of the tracker.

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