Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medacta International S.A. — Predicate Candidate Screening
165 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
270 days90th percentile
165clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | 2026-05-05 | 127 | 0 |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026-04-28 | 140 | 0 |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026-02-26 | 149 | 0 |
| K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026-02-03 | 336 | 1 |
| K251043 | Mpact 3D Metal Implants Extension – DMLS Technology | Medacta International S.A. | 2026-01-28 | 300 | 0 |
| K252847 | NextAR Hip Platform | Medacta International S.A. | 2026-01-09 | 123 | 0 |
| K242603 | MyPAO SA guides | Medacta International S.A. | 2025-11-19 | 446 | 0 |
| K250338 | MSS - Humeral reverse liners extension | Medacta International S.A. | 2025-10-31 | 267 | 0 |
| K250450 | Coated hip implants | Medacta International S.A. | 2025-09-19 | 213 | 0 |
| K252225 | PowerKnot High Strength Sutures | Medacta International S.A. | 2025-09-12 | 58 | 0 |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. | 2025-09-04 | 90 | 0 |
| K241461 | Mpact Constrained Liner | Medacta International S.A. | 2025-07-31 | 434 | 0 |
| K250477 | NextAR(TM) Spine | Medacta International S.A. | 2025-07-31 | 162 | 0 |
| K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025-07-24 | 58 | 0 |
| K251016 | MectaLIF 3D Metal | Medacta International S.A. | 2025-07-17 | 106 | 0 |
| K251933 | SnugFit ASA Extension | Medacta International S.A. | 2025-07-01 | 7 | 0 |
| K251166 | Mfinity Femoral System | Medacta International S.A. | 2025-06-13 | 59 | 0 |
| K243697 | MySpine WebPlanner | Medacta International S.A. | 2025-04-23 | 145 | 0 |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | 2025-04-23 | 267 | 0 |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. | 2025-03-06 | 259 | 0 |
| K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | 2025-01-30 | 267 | 0 |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw Syste | Medacta International S.A. | 2024-06-12 | 57 | 0 |
| K232733 | Mbrace Cable | Medacta International S.A. | 2024-05-03 | 239 | 0 |
| K233172 | NextAR™ Spine Platform | Medacta International S.A. | 2024-04-24 | 209 | 0 |
| K234048 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2024-02-13 | 54 | 0 |
| K231515 | MySpine Cervical Guides | Medacta International S.A. | 2023-12-07 | 196 | 0 |
| K231911 | Glenoid Reconstruction System – Full Wedge Baseplate | Medacta International S.A. | 2023-11-09 | 133 | 0 |
| K232280 | NextAR™ TSA Platform | Medacta International S.A. | 2023-10-29 | 90 | 0 |
| K232123 | MectaLIF Anterior Lag Extension | Medacta International S.A. | 2023-10-18 | 93 | 0 |
| K230011 | Mpact Extension | Medacta International S.A. | 2023-09-20 | 260 | 0 |
| K223769 | NextAR™ Spine Platform | Medacta International S.A. | 2023-07-21 | 218 | 0 |
| K231483 | MySpine Unilateral Guides | Medacta International S.A. | 2023-07-21 | 59 | 0 |
| K231037 | MyKnee UNI-ST | Medacta International S.A. | 2023-06-09 | 58 | 0 |
| K220706 | MyPAO Guides | Medacta International S.A. | 2023-05-30 | 446 | 0 |
| K230544 | SnugFit All-Suture Anchor extension | Medacta International S.A. | 2023-04-17 | 48 | 0 |
| K223582 | MectaLock TI Triple Loaded Suture Anchor | Medacta International S.A. | 2023-02-24 | 85 | 0 |
| K221725 | Advanced MyHip Planner | Medacta International S.A. | 2023-01-20 | 220 | 0 |
| K223548 | GMK Sphere & GMK SpheriKA Cementless | Medacta International S.A. | 2023-01-20 | 56 | 0 |
| K223795 | FairFix QT Adjustable Button | Medacta International S.A. | 2023-01-17 | 29 | 0 |
| K213459 | Glenoid Reconstruction System | Medacta International S.A. | 2022-11-23 | 392 | 0 |
| K221545 | MectaLIF Anterior Extension | Medacta International S.A. | 2022-10-24 | 150 | 6 |
| K221850 | GMK 3D Metal Tibial Tray | Medacta International S.A. | 2022-08-23 | 57 | 0 |
| K222169 | FairFix Adjustable Button System | Medacta International S.A. | 2022-08-16 | 26 | 0 |
| K211891 | DM Converter - TiN coated | Medacta International S.A. | 2022-07-22 | 396 | 0 |
| K221389 | FairFix AM Adjustable Button FairFix PSP Adjustable Button | Medacta International S.A. | 2022-06-08 | 26 | 0 |
| K220888 | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides | Medacta International S.A. | 2022-05-24 | 57 | 0 |
| K212327 | M-Vizion Monobloc | Medacta International S.A. | 2022-05-24 | 301 | 0 |
| K220705 | MyKnee R Pin Positioners | Medacta International S.A. | 2022-05-04 | 55 | 0 |
| K220570 | M.U.S.T. MINI Posterior Cervical Screws System Extension | Medacta International S.A. | 2022-04-26 | 57 | 0 |
| K220405 | Amis K Long | Medacta International S.A. | 2022-04-12 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda