# Depuy Mitek, A Johnson & Johnson Company

- Location (FDA's records): Raynham, MA
- FDA decisions: 59 (2004–2015): 59 510(k) clearances
- Names in FDA's records: Depuy Mitek, A Johnson & Johnson Company (58); Depuy Mitek, A Johnson & Johnson Co. (1)
- Product codes: MAI (18), HWC (13), JDR (7), MBI (7), GEI (6), HRX (4), GAM (3), HTY (1)
- Predicates its devices cite: 176 (70 its own); citations of its devices by later devices: 146 (70 its own)
- Recalls linked to its devices: 46 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mitek Products: 29 (https://510kreport.com/company/mitek-products)
- Mitek Worldwide: 15 (https://510kreport.com/company/mitek-worldwide)
- Arthrex, Inc.: 15 (https://510kreport.com/company/arthrex)
- Depuy Mitek: 11 (https://510kreport.com/company/depuy-mitek)
- Future Medical Systems, Inc.: 6 (https://510kreport.com/company/future-medical-systems)
- Mitek Surgical Products, Inc.: 5 (https://510kreport.com/company/mitek-surgical-products)
- Smith & Nephew, Inc.: 4 (https://510kreport.com/company/smith-nephew)
- ETHICON, Inc.: 4 (https://510kreport.com/company/ethicon)

## Firms that cite its devices most
- Medos International SARL: 16 (https://510kreport.com/company/medos-international)
- Depuy Mitek: 10 (https://510kreport.com/company/depuy-mitek)
- Depuy Mitek, Inc., A Johnson and Johnson Company: 8 (https://510kreport.com/company/depuy-mitek-a-johnson-and-johnson)
- Parcus Medical, LLC: 3 (https://510kreport.com/company/parcus-medical)
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- Bovie Medical Corporation: 3 (https://510kreport.com/company/bovie-medical)
- Ortho-Design (Pty), Ltd.: 3 (https://510kreport.com/company/ortho-design)
- Renovo, Inc.: 3 (https://510kreport.com/company/renovo)

## Its most-cited devices
- K060830: Milagro Interference Screw (2006), cited by 10
- K073412: Gryphon BR and Healix BR Anchors (2008), cited by 10
- K100012: Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS Anchor W/Orthocord, Gryphon P BR a (2010), cited by 8
- K090124: Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814 (2009), cited by 7
- K071257: Mini Quickanchor and Quickanchor Plus with Orthocord (2007), cited by 6
- K130917: Healix Advance Knotless BR Anchor (2013), cited by 6

## Recent decisions
- K143660: Milagro / Milagro Advance Interference Screw (May 21, 2015)
- K142574: 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, (Oct 24, 2014)
- K140896: Vapr Arctic Suction Electrode (Aug 5, 2014)
- K141259: Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek Anchor with Permacord, Gryphon Peek (Jun 10, 2014)
- K133794: 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix Advance BR Anchor, with 2 or 3 (Feb 4, 2014)
- K132241: Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip, Gryphon Peek Anchor W/ Proknot T (Nov 5, 2013)
- K130814: Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM (Aug 1, 2013)
- K131974: Healix Advance Knotless BR Anchor (6.5MM) (Jul 25, 2013)

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