Cleared Traditional

DeGen Medical Patient Specific Implant (PSI) System

K251829 · Degen Medical · Orthopedic

Dec 2025

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K251829 is an FDA 510(k) clearance for the DeGen Medical Patient Specific Implant (PSI) System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Degen Medical (Florence, US). The FDA issued a Cleared decision on December 8, 2025, 178 days after receiving the submission on June 13, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K251829 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2025
Decision Date	December 08, 2025
Days to Decision	178 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.