WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / December 2025 / K250679

510(k) cleared

FFX Facet Fixation System

Sc Medica · Dec 4, 2025 · K250679

FDA cleared the FFX Facet Fixation System from Sc Medica on Dec 4, 2025 under K250679, 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 Mar 6, 2025. The decision came 273 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Sc Medica in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250679?

K250679 is the FDA 510(k) for FFX Facet Fixation System, submitted by Sc Medica. FDA's decision date was Dec 4, 2025, under product code MRW (System, Facet Screw Spinal Device).

Who makes the FFX Facet Fixation System?

Sc Medica, based in Strasbourg, is the applicant of record for K250679.

How long did the K250679 review take?

FDA received the submission on Mar 6, 2025 and issued its decision on Dec 4, 2025, 273 days later.

← All decisions in December 2025