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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 / October 2026 / K261611

510(k) cleared

TDM Large Bone Plate and Screw System

Tdm Co., Ltd. · Oct 2, 2026 · K261611

FDA cleared the TDM Large Bone Plate and Screw System from Tdm Co., Ltd. on Oct 2, 2026 under K261611, 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 May 15, 2026. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Tdm Co., Ltd. has one other decision in the tracker over the last 12 months: K263062 (NOVIX Pedicle Screw System).

Questions & Answers

What did FDA clear under K261611?

K261611 is the FDA 510(k) for TDM Large Bone Plate and Screw System, submitted by Tdm Co., Ltd.. FDA's decision date was Oct 2, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the TDM Large Bone Plate and Screw System?

Tdm Co., Ltd., based in Gwangju, is the applicant of record for K261611.

How long did the K261611 review take?

FDA received the submission on May 15, 2026 and issued its decision on Oct 2, 2026, 140 days later.

← All decisions in October 2026