Medacta International: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Medacta International” (first 2011, latest 2016), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 96 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 9 | 64 |
| 2013 | 9 | 134 |
| 2014 | 8 | 118 |
| 2015 | 3 | 144 |
| 2016 | 3 | 107 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 10 | 10 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 10 | 10 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (39)
Most recent Medacta International 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160605 | MectaLIF Anterior Stand-Alone | OVD | 2016-07-21 | 141 |
| K160289 | MasterLoc Stem | LZO | 2016-05-20 | 107 |
| K153664 | M.U.S.T. Pedicle Screw System | NKB | 2016-01-19 | 29 |
| K151531 | MasterLoc Stem | LZO | 2015-10-30 | 144 |
| K142744 | Mecta-C TiPEEK | ODP | 2015-05-07 | 225 |
| K143453 | Mpact Double Mobility System | LPH | 2015-03-02 | 89 |
| K142069 | GMK EXTENSION | JWH | 2014-12-02 | 125 |
| K141988 | M.U.S.T PEDICLE SCREW SYSTEM | NKB | 2014-08-19 | 28 |
| K141044 | M.U.S.T. EXTENSION | NKB | 2014-08-18 | 117 |
| K140826 | GMK SPHERE EXTENSION | JWH | 2014-07-15 | 105 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medacta International.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medacta International S.A. (167 510(k)s)
- Medacta Inernational SA (4 510(k)s)
- Medacta International SA (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medacta International?
FDA lists 39 510(k) clearances under the applicant name “Medacta International” (first 2011, latest 2016), across 12 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medacta International?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medacta International is 96 days.
Which FDA product codes appear under Medacta International?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 10); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 10); NKB (Thoracolumbosacral Pedicle Screw System, 4).
Next steps
- See all 39 Medacta International clearances with predicates and recalls
- Run predicate analysis for product code JWH, Medacta International's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.