Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Depuy Mitek — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
119 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243790 | GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor | Depuy Mitek | 2025-02-05 | 57 | 0 |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punchin | Depuy Mitek | 2024-09-11 | 152 | 0 |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Scr | Depuy Mitek | 2024-03-15 | 30 | 0 |
| K143475 | VAPR Tripolar Suction Electrode | Depuy Mitek | 2015-04-03 | 119 | 1 |
| K120449 | HEALIX ADVANCE PEEK ANCHOR | Depuy Mitek | 2012-05-11 | 87 | 0 |
| K080918 | DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENI | Depuy Mitek | 2008-04-23 | 22 | 0 |
| K060664 | FASTIN RC ANCHOR | Depuy Mitek | 2006-06-06 | 85 | 0 |
| K043298 | BLUE ORTHOCORD SUTURE | Depuy Mitek | 2004-12-10 | 10 | 6 |
| K041117 | PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTU | Depuy Mitek | 2004-05-28 | 29 | 0 |
| K041116 | SUPER QUICKANCHOR PLUS | Depuy Mitek | 2004-05-28 | 29 | 0 |
| K041064 | BIOKNOTLESS RC ANCHOR | Depuy Mitek | 2004-05-13 | 20 | 0 |
| K041065 | PANALOK RC LOOP ANCHOR | Depuy Mitek | 2004-05-07 | 14 | 0 |
| K040004 | ORTHOCORD SUTURE | Depuy Mitek | 2004-04-13 | 102 | 1 |
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