Medacta International S.A. - FDA 510(k) Cleared Devices
Recent clearances: MectaLIF 3D Metal Anterior, M.U.S.T. Pedicle Screw System - Extension, GMK 3D Metal Tibial Tray Extension
165
Total
165
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medacta International S.A. Orthopedic ✕
158 devices
Cleared
May 05, 2026
MectaLIF 3D Metal Anterior
Orthopedic
127d
Cleared
Apr 28, 2026
M.U.S.T. Pedicle Screw System - Extension
Orthopedic
140d
Cleared
Feb 26, 2026
GMK 3D Metal Tibial Tray Extension
Orthopedic
149d
Cleared
Feb 03, 2026
MSS - Monobloc stem
Orthopedic
336d
Cleared
Jan 28, 2026
Mpact 3D Metal Implants Extension – DMLS Technology
Orthopedic
300d
Cleared
Jan 09, 2026
NextAR Hip Platform
Orthopedic
123d
Cleared
Nov 19, 2025
MyPAO SA guides
Orthopedic
446d
Cleared
Oct 31, 2025
MSS - Humeral reverse liners extension
Orthopedic
267d
Cleared
Sep 19, 2025
Coated hip implants
Orthopedic
213d
Cleared
Sep 04, 2025
NextAR(TM) Shoulder Platform
Orthopedic
90d
Cleared
Jul 31, 2025
Mpact Constrained Liner
Orthopedic
434d
Cleared
Jul 31, 2025
NextAR(TM) Spine
Orthopedic
162d
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