Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Depuy Mitek, 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) |
|---|---|---|---|---|---|
| K150209 | Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryp | Depuy Mitek, A Johnson and Johnson Company | 2015-10-06 | 249 | 5 |
| K140643 | GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W | Depuy Mitek, A Johnson and Johnson Company | 2014-07-08 | 118 | 0 |
| K140324 | RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL | Depuy Mitek, A Johnson and Johnson Company | 2014-07-07 | 147 | 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