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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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.

Degen Medical has one other decision in the tracker over the last 12 months: K252737 (DeGen Medical Latitude-C AM Cervical Interbody Fusion System).

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

Sources