Medacta International S.A.: FDA clearances and approvals
Medacta International S.A. has 167 FDA 510(k) clearances (first 2008, latest 2026), across 38 product codes in 4 review panels. Median 510(k) review time: 94 days. Since 2017 its median was 94 days, against 100 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 56 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 3 | 87 |
| 2017 | 20 | 142 |
| 2018 | 10 | 154 |
| 2019 | 13 | 90 |
| 2020 | 23 | 87 |
| 2021 | 25 | 79 |
| 2022 | 13 | 57 |
| 2023 | 14 | 92 |
| 2024 | 4 | 133 |
| 2025 | 15 | 162 |
| 2026 | 8 | 194 |
Review time against the same product codes
Since 2017, Medacta International S.A.'s cleared 510(k)s took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 28 | 28 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 17 | 17 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 15 | 15 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 12 | 12 |
| SBF | Orthopedic Augmented Reality | 10 | 10 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 8 | 8 |
| NKB | Thoracolumbosacral Pedicle Screw System | 8 | 8 |
| NKG | Posterior Cervical Screw System | 6 | 6 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 5 | 5 |
Plus 28 more product codes.
Review panels
- Orthopedic (160)
- Radiology (5)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Medacta International S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260173 | M-Vizion Femoral Revision System Extension | LZO | 2026-09-17 | 239 |
| K253630 | Mpact 3D Metal Foam | LPH | 2026-08-28 | 282 |
| K254202 | MectaLIF 3D Metal Anterior | OVD | 2026-05-05 | 127 |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | NKB | 2026-04-28 | 140 |
| K253328 | GMK 3D Metal Tibial Tray Extension | MBH | 2026-02-26 | 149 |
| K250644 | MSS - Monobloc stem | PHX | 2026-02-03 | 336 |
| K251043 | Mpact 3D Metal Implants Extension DMLS Technology | LPH | 2026-01-28 | 300 |
| K252847 | NextAR Hip Platform | SBF | 2026-01-09 | 123 |
| K242603 | MyPAO SA guides | PBF | 2025-11-19 | 446 |
| K250338 | MSS - Humeral reverse liners extension | PHX | 2025-10-31 | 267 |
157 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medacta International S.A..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medacta International S.A. have?
Medacta International S.A. has 167 FDA 510(k) clearances (first 2008, latest 2026), across 38 product codes in 4 review panels.
How long does FDA take to clear Medacta International S.A.'s 510(k)s?
The median time from FDA receipt to decision across Medacta International S.A.'s cleared 510(k)s is 94 days. Since 2017: 94 days, versus 100 days for all cleared 510(k)s in the same product codes.
What devices does Medacta International S.A. make?
Its most frequent FDA product codes are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 28); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 17); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 15).
Has Medacta International S.A. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medacta International S.A. Related entities may recall under other names.
Next steps
- See all 167 Medacta International S.A. clearances with predicates and recalls
- Run predicate analysis for product code LZO, Medacta International S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.