Medacta International S.A.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 202
- Inspections
- 5
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253328 | GMK 3D Metal Tibial Tray Extension | February 26, 2026 |
| K250644 | MSS - Monobloc stem | February 3, 2026 |
| K251043 | Mpact 3D Metal Implants Extension DMLS Technology | January 28, 2026 |
| K252847 | NextAR Hip Platform | January 9, 2026 |
| K242603 | MyPAO SA guides | November 19, 2025 |
| K250338 | MSS - Humeral reverse liners extension | October 31, 2025 |
| K250450 | Coated hip implants | September 19, 2025 |
| K252225 | PowerKnot High Strength Sutures | September 12, 2025 |
| K251737 | NextAR(TM) Shoulder Platform | September 4, 2025 |
| K241461 | Mpact Constrained Liner | July 31, 2025 |
| K250477 | NextAR(TM) Spine | July 31, 2025 |
| K251618 | MOTO Partial Knee System Extension | July 24, 2025 |
| K251016 | MectaLIF 3D Metal | July 17, 2025 |
| K251933 | SnugFit ASA Extension | July 1, 2025 |
| K251166 | Mfinity Femoral System | June 13, 2025 |
| K242232 | Mpact 3D Metal Augments II | April 23, 2025 |
| K243697 | MySpine WebPlanner | April 23, 2025 |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | March 6, 2025 |
| K241292 | MyShoulder Planner (5.3SSWPL) | January 30, 2025 |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | June 12, 2024 |