Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tornier S.A.S. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
156 daysmedian FDA review time
255 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232265 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2024-02-21 | 205 | 0 |
| K222510 | Blueprint Mixed Reality system | Tornier S.A.S. | 2023-01-20 | 154 | 10 |
| DEN220012 | Tornier Pyrocarbon Humeral Head | Tornier S.A.S. | 2022-12-16 | 311 | 0 |
| K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021-04-15 | 156 | 0 |
| K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019-06-12 | 100 | 0 |
| K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017-02-22 | 140 | 0 |
| K161789 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016-12-27 | 181 | 0 |
| K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | 2016-08-11 | 255 | 0 |
| K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016-06-10 | 102 | 0 |
| K152966 | Aequalis Fx2 | Tornier S.A.S. | 2016-01-14 | 99 | 0 |
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shou | Tornier S.A.S. | 2015-09-24 | 132 | 0 |
| K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015-04-08 | 134 | 0 |
| K141345 | AEQUALIS FX2 | Tornier S.A.S. | 2014-11-18 | 180 | 0 |
| K140478 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Tornier S.A.S. | 2014-08-06 | 161 | 0 |
| K140082 | AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM | Tornier S.A.S. | 2014-07-18 | 186 | 0 |
| K132285 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Tornier S.A.S. | 2013-12-05 | 135 | 0 |
| K131231 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDE | Tornier S.A.S. | 2013-10-16 | 169 | 0 |
| K130051 | 611 ANKLE FUSION NAIL | Tornier S.A.S. | 2013-07-15 | 187 | 0 |
| K130533 | SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS | Tornier S.A.S. | 2013-05-17 | 77 | 1 |
| K122698 | AEQUALIS ASCEND FLEX SHOULDER SYSTEM | Tornier S.A.S. | 2013-01-08 | 126 | 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