Cleared Traditional

DeGen Medical Patient Specific Implant (PSI) System (K241077) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241077 · Degen Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
193d
Days
Class 2
Risk

K241077 is an FDA 510(k) clearance for the DeGen Medical Patient Specific Implant (PSI) System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Degen Medical (Florence, US). The FDA issued a Cleared decision on October 29, 2024 after a review of 193 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Degen Medical devices

Submission Details

510(k) Number K241077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2024
Decision Date October 29, 2024
Days to Decision 193 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 122d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Secure BioMed Evaluations
Justin Gracyalny

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 111
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K241077.
aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation
K243802 · Carlsmed, Inc. · Mar 2025
aprevo® anterior lumbar interbody fusion device with interfixation
K243635 · Carlsmed, Inc. · Dec 2024
Atlas Spine Lateral Expandable Interbody System
K243191 · Atlas Spine, Inc. · Nov 2024
Catalyft™ LS Expandable Interbody System
K241992 · Medtronic Sofamor Danek USA, Inc. · Oct 2024
aprevo® anterior lumbar interbody fusion device with interfixation
K241477 · Carlsmed, Inc. · Oct 2024
Interwedge® Standalone Lateral
K241487 · Foundation Surgical Group, Inc. · Oct 2024