Tornier S.A.S.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Tornier S.A.S.” (first 2013, latest 2024), plus 1 De Novo decision, across 6 product codes in 1 review panel. Median 510(k) review time under this name: 154 days. Since 2017 the median was 154 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 5 | 135 |
| 2014 | 3 | 180 |
| 2015 | 2 | 133 |
| 2016 | 4 | 142 |
| 2017 | 1 | 140 |
| 2018 | 0 | — |
| 2019 | 1 | 100 |
| 2020 | 0 | — |
| 2021 | 1 | 156 |
| 2022 | 0 | — |
| 2023 | 1 | 154 |
| 2024 | 1 | 205 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tornier S.A.S. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 8 | 8 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 7 | 7 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| QKW | Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis | 1 | 0 |
Review panels
- Orthopedic (20)
Most recent Tornier S.A.S. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232265 | BLUEPRINT Patient Specific Instrumentation | PHX | 2024-02-21 | 205 |
| K222510 | Blueprint Mixed Reality system | OLO | 2023-01-20 | 154 |
| K203315 | BLUEPRINT Patient Specific Instrumentation | KWS | 2021-04-15 | 156 |
| K190521 | Aequalis Ascend Flex Shoulder System | KWS | 2019-06-12 | 100 |
| K162800 | BLUEPRINT Patient Specific Instrumentation | KWS | 2017-02-22 | 140 |
| K161789 | BLUEPRINT Patient Specific Instrumentation | KWS | 2016-12-27 | 181 |
| K153452 | Salto XT, Salto Talaris | HSN | 2016-08-11 | 255 |
| K160555 | BLUEPRINT Patient Specific Instrumentation | KWS | 2016-06-10 | 102 |
| K152966 | Aequalis Fx2 | PHX | 2016-01-14 | 99 |
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | KWS | 2015-09-24 | 132 |
9 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220012 | De Novo | Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis | 2022-12-16 |
Recalls
13 product recalls in 5 recall events; 12 initiated in the last five years. Most recent: 2025-04-10.
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.
- Tornier, Inc. (96 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tornier S.A.S.?
FDA lists 19 510(k) clearances under the applicant name “Tornier S.A.S.” (first 2013, latest 2024), plus 1 De Novo decision, across 6 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 Tornier S.A.S.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tornier S.A.S. is 154 days. Since 2017: 154 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tornier S.A.S.?
The most frequent FDA product codes under this applicant name are KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, 8); PHX (Shoulder Prosthesis, Reverse Configuration, 7); HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer, 2).
Next steps
- See all 19 Tornier S.A.S. clearances with predicates and recalls
- Run predicate analysis for product code KWS, Tornier S.A.S.'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.