Cleared Traditional

Atlas Spine Project X Expandable Posterior Lumbar Interbody System

K251969 · Atlas Spine, Inc. · Orthopedic

Aug 2025

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K251969 is an FDA 510(k) clearance for the Atlas Spine Project X Expandable Posterior Lumbar Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on August 15, 2025, 50 days after receiving the submission on June 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K251969 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2025
Decision Date	August 15, 2025
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

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.