Medical Device Manufacturer · CH , Castel San Pietro

Medacta International S.A.

163 submissions · 163 cleared · Since 2008
163
Total
163
Cleared
0
Denied

Medacta International S.A. — FDA 510(k) Submissions

Medacta International S.A. has submitted 163 FDA 510(k) premarket notifications since 2008, of which 163 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Fastener, Fixation, Nondegradable, Soft Tissue, Shoulder Prosthesis, Reverse Configuration, Orthopedic Augmented Reality . Use the specialty filter in the sidebar to narrow results.

163 devices
1–25 of 163
GMK 3D Metal Tibial Tray Extension
K253328 · MBH Prosthesis, Knee,... · Orthopedic
Feb 2026 149d
MSS - Monobloc stem
K250644 · PHX Shoulder Prosthesis,... · Orthopedic
Feb 2026 336d
Mpact 3D Metal Implants Extension ? DMLS Technology
K251043 · LPH Prosthesis, Hip,... · Orthopedic
Jan 2026 300d
NextAR Hip Platform
K252847 · SBF Orthopedic Augmented Reality · Orthopedic
Jan 2026 123d
MyPAO SA guides
K242603 · PBF Orthopaedic Surgical... · Orthopedic
Nov 2025 446d
MSS - Humeral reverse liners extension
K250338 · PHX Shoulder Prosthesis,... · Orthopedic
Oct 2025 267d
Coated hip implants
K250450 · LZO Prosthesis, Hip,... · Orthopedic
Sep 2025 213d
PowerKnot High Strength Sutures
K252225 · GAT Suture, Nonabsorbable,... · General & Plastic Surgery
Sep 2025 58d
NextAR(TM) Shoulder Platform
K251737 · SBF Orthopedic Augmented Reality · Orthopedic
Sep 2025 90d
Mpact Constrained Liner
K241461 · KWZ Prosthesis, Hip,... · Orthopedic
Jul 2025 434d
NextAR(TM) Spine
K250477 · SBF Orthopedic Augmented Reality · Orthopedic
Jul 2025 162d
MOTO Partial Knee System Extension
K251618 · HSX Prosthesis, Knee,... · Orthopedic
Jul 2025 58d
MectaLIF 3D Metal
K251016 · MAX Intervertebral Fusion... · Orthopedic
Jul 2025 106d
SnugFit ASA Extension
K251933 · MBI Fastener, Fixation,... · Orthopedic
Jul 2025 7d
Mfinity Femoral System
K251166 · MEH Prosthesis, Hip,... · Orthopedic
Jun 2025 59d
Mpact 3D Metal Augments II
K242232 · LPH Prosthesis, Hip,... · Orthopedic
Apr 2025 267d
MySpine WebPlanner
K243697 · LLZ System, Image Processing,... · Radiology
Apr 2025 145d
Versacem Acetabular Shell and Double Mobility HC Liners
K241767 · LZO Prosthesis, Hip,... · Orthopedic
Mar 2025 259d
MyShoulder Planner (5.3SSWPL)
K241292 · KWS Prosthesis, Shoulder,... · Orthopedic
Jan 2025 267d
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
K241034 · PML Bone Cement, Posterior... · Orthopedic
Jun 2024 57d
Mbrace Cable
K232733 · JDQ Cerclage, Fixation · Orthopedic
May 2024 239d
NextAR? Spine Platform
K233172 · SBF Orthopedic Augmented Reality · Orthopedic
Apr 2024 209d
M.U.S.T. Pedicle Screw System - Extension
K234048 · NKB Thoracolumbosacral... · Orthopedic
Feb 2024 54d
MySpine Cervical Guides
K231515 · QSD Posterior Cervical Screw... · Orthopedic
Dec 2023 196d
Glenoid Reconstruction System ? Full Wedge Baseplate
K231911 · PHX Shoulder Prosthesis,... · Orthopedic
Nov 2023 133d

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