Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stryker Corporation (Tornier, Inc.) — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reverse | Stryker Corporation (Tornier, Inc.) | 2026-06-12 | 150 | 0 |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier | Stryker Corporation (Tornier, Inc.) | 2024-12-06 | 161 | 0 |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | 2024-09-10 | 97 | 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