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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 / January 2026 / K251714

510(k) cleared

Ion-C

SurGenTec, LLC · Jan 16, 2026 · K251714

FDA cleared the Ion-C from SurGenTec, LLC on Jan 16, 2026 under K251714, a traditional 510(k). The device falls under product code MRW, System, Facet Screw Spinal Device as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jun 3, 2025. The decision came 227 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SurGenTec, LLC has 7 other decisions in the tracker over the last 12 months: K252995 (Durashield Device Kit), K262581 (GraftGun Universal Graft Delivery System (GDS®)), K261381 (TiLink-L SI Joint Fusion System), K262121 (Ion-L Navigated Instruments).

Questions & Answers

What did FDA clear under K251714?

K251714 is the FDA 510(k) for Ion-C, submitted by SurGenTec, LLC. FDA's decision date was Jan 16, 2026, under product code MRW (System, Facet Screw Spinal Device).

Who makes the Ion-C?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K251714.

How long did the K251714 review take?

FDA received the submission on Jun 3, 2025 and issued its decision on Jan 16, 2026, 227 days later.

← All decisions in January 2026