Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Depuy Mitek, Inc., A Johnson and Johnson Company · 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) |
|---|---|---|---|---|---|
| K131683 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013-06-27 | 17 | 0 |
| K123668 | ORTHOCORD | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013-02-26 | 89 | 0 |
| K122123 | 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRA | Depuy Mitek, Inc., A Johnson and Johnson Company | 2012-10-02 | 76 | 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