Cleared Traditional

GMK 3D Metal Tibial Tray Extension

K253328 · Medacta International S.A. · Orthopedic

Feb 2026

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K253328 is an FDA 510(k) clearance for the GMK 3D Metal Tibial Tray Extension, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on February 26, 2026, 149 days after receiving the submission on September 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K253328 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2025
Decision Date	February 26, 2026
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565