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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 / K263116

510(k) cleared

OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts

OsteoCentric Technologies · Oct 2, 2026 · K263116

FDA cleared the OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts from OsteoCentric Technologies on Oct 2, 2026 under K263116, 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 Sep 4, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

OsteoCentric Technologies has one other decision in the tracker over the last 12 months: K250520 (OsteoCentric Navigated Instruments System).

Questions & Answers

What did FDA clear under K263116?

K263116 is the FDA 510(k) for OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts, submitted by OsteoCentric Technologies. FDA's decision date was Oct 2, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts?

OsteoCentric Technologies, based in Logan, UT, is the applicant of record for K263116.

How long did the K263116 review take?

FDA received the submission on Sep 4, 2026 and issued its decision on Oct 2, 2026, 28 days later.

← All decisions in October 2026

Sources