# Mitek Worldwide

- Location (FDA's records): Norwood, MA
- FDA decisions: 10 (2002–2004): 10 510(k) clearances
- Product codes: HWC (5), JDR (2), MAI (1), HRX (1), NOV (1)
- Predicates its devices cite: 18 (0 its own); citations of its devices by later devices: 24 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mitek Products: 10 (https://510kreport.com/company/mitek-products)
- Hydrocision, Inc.: 4 (https://510kreport.com/company/hydrocision)
- Mitek Surgical Products, Inc.: 1 (https://510kreport.com/company/mitek-surgical-products)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)
- Innovasive Devices, Inc.: 1 (https://510kreport.com/company/innovasive-devices)

## Firms that cite its devices most
- Depuy Mitek, A Johnson & Johnson Company: 15 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Axya Medical, Inc.: 2 (https://510kreport.com/company/axya-medical)
- Johnson & Johnson: 2 (https://510kreport.com/company/johnson-johnson)
- Cayenne Medical, Inc.: 1 (https://510kreport.com/company/cayenne-medical)
- First Ray, LLC: 1 (https://510kreport.com/company/first-ray)
- Anchor Innovation Medical, Inc.: 1 (https://510kreport.com/company/anchor-innovation-medical)

## Its most-cited devices
- K032717: Biocryl Rapide Interference Screw (2004), cited by 9
- K032167: Bio-Intrafix Tibial Screw and Sheath (2003), cited by 4
- K030995: Minilok Quickanchor Plus (2003), cited by 3
- K021883: Biofastin RC Threaded Suture Anchor (2002), cited by 3
- K023388: Mitek Rapidloc-PDS Meniscal Repair System (2002), cited by 2
- K024115: Microfix Quickanchor Plus (2003), cited by 1

## Recent decisions
- K032717: Biocryl Rapide Interference Screw (Mar 31, 2004)
- K032167: Bio-Intrafix Tibial Screw and Sheath (Oct 15, 2003)
- K032078: Mitek Micro Quickanchor (Aug 25, 2003)
- K030995: Minilok Quickanchor Plus (Jun 26, 2003)
- K031519: Cufflok Anchor (Jun 6, 2003)
- K031406: Exojet Tissue Management System (May 30, 2003)
- K024115: Microfix Quickanchor Plus (Mar 13, 2003)
- K023388: Mitek Rapidloc-PDS Meniscal Repair System (Dec 27, 2002)

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