Company · US
Depuy Mitek
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JDR | Staple, Fixation, Bone | 4 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 3 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 3 |
| HWC | Screw, Fixation, Bone | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| HRX | Arthroscope | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 26, 2026 | K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid DePuy Mitek, Inc. | KCT |
| Feb 5, 2025 | K243790 | GRYPHON X Anchor; HEALIX TRANSTEND Anchor Depuy Mitek | MAI |
| Sep 11, 2024 | K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors Depuy Mitek | MAI |
| Mar 15, 2024 | K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw Depuy Mitek | MAI |
| Feb 26, 2024 | K233675 | FMS VUE Fluid Management and Tissue Debridement System DePuy Mitek, Inc. | HRX |
| Apr 3, 2015 | K143475 | VAPR Tripolar Suction Electrode Depuy Mitek | GEI |
| May 11, 2012 | K120449 | HEALIX ADVANCE PEEK ANCHOR Depuy Mitek | HWC |
| Apr 23, 2008 | K080918 | DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 Depuy Mitek | NEW |
| Jun 6, 2006 | K060664 | FASTIN RC ANCHOR Depuy Mitek | HWC |
| Dec 10, 2004 | K043298 | BLUE ORTHOCORD SUTURE Depuy Mitek | NEW |
| May 28, 2004 | K041117 | PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 Depuy Mitek | JDR |
| May 28, 2004 | K041116 | SUPER QUICKANCHOR PLUS Depuy Mitek | JDR |
| May 13, 2004 | K041064 | BIOKNOTLESS RC ANCHOR Depuy Mitek | JDR |
| May 7, 2004 | K041065 | PANALOK RC LOOP ANCHOR Depuy Mitek | JDR |
| Apr 13, 2004 | K040004 | ORTHOCORD SUTURE Depuy Mitek | NEW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||