Company · CH
Medacta International S.A.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
208510(k) clearances (11 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 38 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 28 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 15 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 13 |
| NKB | Thoracolumbosacral Pedicle Screw System | 12 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 11 |
| SBF | Orthopedic Augmented Reality | 10 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 8 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 7 |
| NKG | Posterior Cervical Screw System | 6 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 5 |
| LLZ | System, Image Processing, Radiological | 5 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 4 |
| HWC | Screw, Fixation, Bone | 3 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 3 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 |
| OUR | Sacroiliac Joint Fixation | 3 |
| PQC | Pedicle Screw Placement Guide | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 2026 | K260173 | M-Vizion Femoral Revision System Extension Medacta International S.A., CH | LZO |
| Sep 15, 2026 | K262057 | GMK Extension Medacta International SA, CH | JWH |
| Aug 28, 2026 | K253630 | Mpact 3D Metal Foam Medacta International S.A., CH | LPH |
| Jun 10, 2026 | K261016 | MSS - Humeral reverse liners extension Medacta International, SA, CH | PHX |
| May 5, 2026 | K254202 | MectaLIF 3D Metal Anterior Medacta International S.A., CH | OVD |
| Apr 28, 2026 | K253940 | M.U.S.T. Pedicle Screw System - Extension Medacta International S.A., CH | NKB |
| Feb 26, 2026 | K253328 | GMK 3D Metal Tibial Tray Extension Medacta International S.A., CH | MBH |
| Feb 3, 2026 | K250644 | MSS - Monobloc stem Medacta International S.A., CH | PHX |
| Jan 28, 2026 | K251043 | Mpact 3D Metal Implants Extension DMLS Technology Medacta International S.A., CH | LPH |
| Jan 9, 2026 | K252847 | NextAR Hip Platform Medacta International S.A., CH | SBF |
| Nov 19, 2025 | K242603 | MyPAO SA guides Medacta International S.A., CH | PBF |
| Oct 31, 2025 | K250338 | MSS - Humeral reverse liners extension Medacta International S.A., CH | PHX |
| Sep 19, 2025 | K250450 | Coated hip implants Medacta International S.A., CH | LZO |
| Sep 12, 2025 | K252225 | PowerKnot High Strength Sutures Medacta International S.A., CH | GAT |
| Sep 4, 2025 | K251737 | NextAR(TM) Shoulder Platform Medacta International S.A., CH | SBF |
| Jul 31, 2025 | K250477 | NextAR(TM) Spine Medacta International S.A., CH | SBF |
| Jul 31, 2025 | K241461 | Mpact Constrained Liner Medacta International S.A., CH | KWZ |
| Jul 24, 2025 | K251618 | MOTO Partial Knee System Extension Medacta International S.A., CH | HSX |
| Jul 17, 2025 | K251016 | MectaLIF 3D Metal Medacta International S.A., CH | MAX |
| Jul 1, 2025 | K251933 | SnugFit ASA Extension Medacta International S.A., CH | MBI |
| Jun 13, 2025 | K251166 | Mfinity Femoral System Medacta International S.A., CH | MEH |
| Apr 23, 2025 | K243697 | MySpine WebPlanner Medacta International S.A., CH | LLZ |
| Apr 23, 2025 | K242232 | Mpact 3D Metal Augments II Medacta International S.A., CH | LPH |
| Mar 6, 2025 | K241767 | Versacem Acetabular Shell and Double Mobility HC Liners Medacta International S.A., CH | LZO |
| Jan 30, 2025 | K241292 | MyShoulder Planner (5.3SSWPL) Medacta International S.A., CH | KWS |
| Jun 12, 2024 | K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System Medacta International S.A., CH | PML |
| May 3, 2024 | K232733 | Mbrace Cable Medacta International S.A., CH | JDQ |
| Apr 24, 2024 | K233172 | NextAR Spine Platform Medacta International S.A., CH | SBF |
| Feb 13, 2024 | K234048 | M.U.S.T. Pedicle Screw System - Extension Medacta International S.A., CH | NKB |
| Dec 7, 2023 | K231515 | MySpine Cervical Guides Medacta International S.A., CH | QSD |
| Nov 9, 2023 | K231911 | Glenoid Reconstruction System Full Wedge Baseplate Medacta International S.A., CH | PHX |
| Oct 29, 2023 | K232280 | NextAR TSA Platform Medacta International S.A., CH | SBF |
| Oct 18, 2023 | K232123 | MectaLIF Anterior Lag Extension Medacta International S.A., CH | OVD |
| Sep 20, 2023 | K230011 | Mpact Extension Medacta International S.A., CH | LPH |
| Jul 21, 2023 | K231483 | MySpine Unilateral Guides Medacta International S.A., CH | PQC |
| Jul 21, 2023 | K223769 | NextAR Spine Platform Medacta International S.A., CH | SBF |
| Jun 9, 2023 | K231037 | MyKnee UNI-ST Medacta International S.A., CH | JWH |
| May 30, 2023 | K220706 | MyPAO Guides Medacta International S.A., CH | PBF |
| Apr 17, 2023 | K230544 | SnugFit All-Suture Anchor extension Medacta International S.A., CH | MBI |
| Feb 24, 2023 | K223582 | MectaLock TI Triple Loaded Suture Anchor Medacta International S.A., CH | MBI |
| Jan 20, 2023 | K223548 | GMK Sphere & GMK SpheriKA Cementless Medacta International S.A., CH | MBH |
| Jan 20, 2023 | K221725 | Advanced MyHip Planner Medacta International S.A., CH | LLZ |
| Jan 17, 2023 | K223795 | FairFix QT Adjustable Button Medacta International S.A., CH | MBI |
| Nov 23, 2022 | K213459 | Glenoid Reconstruction System Medacta International S.A., CH | PHX |
| Oct 24, 2022 | K221545 | MectaLIF Anterior Extension Medacta International S.A., CH | OVD |
| Aug 23, 2022 | K221850 | GMK 3D Metal Tibial Tray Medacta International S.A., CH | MBH |
| Aug 16, 2022 | K222169 | FairFix Adjustable Button System Medacta International S.A., CH | MBI |
| Jul 22, 2022 | K211891 | DM Converter - TiN coated Medacta International S.A., CH | LZO |
| Jun 8, 2022 | K221389 | FairFix AM Adjustable Button FairFix PSP Adjustable Button Medacta International S.A., CH | MBI |
| May 24, 2022 | K220888 | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides Medacta International S.A., CH | QSR |
Newest 50 of 208.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||