Cleared Traditional

SWINGO-3D Lumbar Cage System

K254017 · Implanet · Orthopedic

Feb 2026

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K254017 is an FDA 510(k) clearance for the SWINGO-3D Lumbar Cage System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Implanet (Allee Francois Magendie, FR). The FDA issued a Cleared decision on February 26, 2026, 73 days after receiving the submission on December 15, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K254017 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2025
Decision Date	February 26, 2026
Days to Decision	73 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.