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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 2025 / K250520

510(k) cleared

OsteoCentric Navigated Instruments System

Osteocentric Technologies, Inc. · Oct 27, 2025 · K250520

FDA cleared the OsteoCentric Navigated Instruments System from Osteocentric Technologies, Inc. on Oct 27, 2025 under K250520, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 21, 2025. The decision came 248 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Osteocentric Technologies, Inc. has one other decision in the tracker over the last 12 months: K263116 (OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts).

Questions & Answers

What did FDA clear under K250520?

K250520 is the FDA 510(k) for OsteoCentric Navigated Instruments System, submitted by Osteocentric Technologies, Inc.. FDA's decision date was Oct 27, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the OsteoCentric Navigated Instruments System?

Osteocentric Technologies, Inc., based in Logan, UT, is the applicant of record for K250520.

How long did the K250520 review take?

FDA received the submission on Feb 21, 2025 and issued its decision on Oct 27, 2025, 248 days later.

← All decisions in October 2025

Sources