Cleared Special

Titanium Interbody System

K253266 · Spine Innovation, LLC · Orthopedic

Jan 2026

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K253266 is an FDA 510(k) clearance for the Titanium Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Spine Innovation, LLC (Coronado, US). The FDA issued a Cleared decision on January 8, 2026, 101 days after receiving the submission on September 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K253266 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	January 08, 2026
Days to Decision	101 days
Submission Type	Special
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.