# Depuy Mitek

- Location (FDA's records): Raynham, MA
- FDA decisions: 15 (2004–2026): 15 510(k) clearances
- Names in FDA's records: Depuy Mitek (13); DePuy Mitek, Inc. (2)
- Product codes: JDR (4), NEW (3), MAI (3), HWC (2), KCT (1), GEI (1), HRX (1)
- 510(k) review time since 2016: median 90 days, against 54 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 31 (3 its own); citations of its devices by later devices: 26 (3 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy Mitek, A Johnson & Johnson Company: 10 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Medos International SARL: 6 (https://510kreport.com/company/medos-international)
- Mitek Products: 5 (https://510kreport.com/company/mitek-products)
- Arthrex, Inc.: 4 (https://510kreport.com/company/arthrex)
- Mitek Surgical Products, Inc.: 2 (https://510kreport.com/company/mitek-surgical-products)
- Synthes: 1 (https://510kreport.com/company/synthes)

## Firms that cite its devices most
- Depuy Mitek, A Johnson & Johnson Company: 11 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Medos International SARL: 3 (https://510kreport.com/company/medos-international)
- Depuy Mitek, Inc., A Johnson and Johnson Company: 2 (https://510kreport.com/company/depuy-mitek-a-johnson-and-johnson)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Amendia, Inc.: 1 (https://510kreport.com/company/amendia)
- Extremity Medical, LLC: 1 (https://510kreport.com/company/extremity-medical)
- Cp Medical: 1 (https://510kreport.com/company/cp-medical)
- OSSIO, Ltd.: 1 (https://510kreport.com/company/ossio)

## Its most-cited devices
- K040004: Orthocord Suture (2004), cited by 10
- K043298: Blue Orthocord Suture (2004), cited by 5
- K120449: Healix Advance Peek Anchor (2012), cited by 4
- K060664: Fastin RC Anchor (2006), cited by 3
- K041116: Super Quickanchor Plus (2004), cited by 1
- K240441: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw (2024), cited by 1

## Recent decisions
- K253791: PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (Feb 26, 2026)
- K243790: GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (Feb 5, 2025)
- K241010: HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors (Sep 11, 2024)
- K240441: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw (Mar 15, 2024)
- K233675: FMS VUE™ Fluid Management and Tissue Debridement System (Feb 26, 2024)
- K143475: VAPR Tripolar Suction Electrode (Apr 3, 2015)
- K120449: Healix Advance Peek Anchor (May 11, 2012)
- K080918: Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet & 3 Free Strands of Size #2-0 (Apr 23, 2008)

Source page: https://510kreport.com/company/depuy-mitek