Cleared Traditional

LUX Expandable Lumbar Interbody System

K253583 · Xenix Medical · Orthopedic

Feb 2026

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K253583 is an FDA 510(k) clearance for the LUX Expandable Lumbar Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Xenix Medical (Orlando, US). The FDA issued a Cleared decision on February 23, 2026, 98 days after receiving the submission on November 17, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K253583 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2025
Decision Date	February 23, 2026
Days to Decision	98 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.