Cleared Traditional

Endoskeleton? Interbody Systems

K251444 · Medtronic Sofamor Danek USA, Inc. · Orthopedic

Sep 2025

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K251444 is an FDA 510(k) clearance for the Endoskeleton? Interbody Systems, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on September 4, 2025, 118 days after receiving the submission on May 9, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K251444 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2025
Decision Date	September 04, 2025
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.