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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 / December 2025 / K251829

510(k) cleared

DeGen Medical Patient Specific Implant (PSI) System

Degen Medical · Dec 8, 2025 · K251829

FDA cleared the DeGen Medical Patient Specific Implant (PSI) System from Degen Medical on Dec 8, 2025 under K251829, a traditional 510(k). The device falls under product code OVD, Intervertebral Fusion Device With Integrated Fixation, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 13, 2025. The decision came 178 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 Degen Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251829?

K251829 is the FDA 510(k) for DeGen Medical Patient Specific Implant (PSI) System, submitted by Degen Medical. FDA's decision date was Dec 8, 2025, under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

Who makes the DeGen Medical Patient Specific Implant (PSI) System?

Degen Medical, based in Florence, SC, is the applicant of record for K251829.

How long did the K251829 review take?

FDA received the submission on Jun 13, 2025 and issued its decision on Dec 8, 2025, 178 days later.

← All decisions in December 2025