Cleared Traditional

MectaLIF 3D Metal

K251016 · Medacta International S.A. · Orthopedic

Jul 2025

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K251016 is an FDA 510(k) clearance for the MectaLIF 3D Metal, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on July 17, 2025, 106 days after receiving the submission on April 2, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K251016 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 2025
Decision Date	July 17, 2025
Days to Decision	106 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.