# Mitek Products

- Location (FDA's records): Westwood, MA
- FDA decisions: 30 (1996–2002): 30 510(k) clearances
- Product codes: MBI (7), HWC (4), GEI (4), MAI (3), HTY (3), DZL (3), HRX (2), JDR (2), GAM (1), HWQ (1)
- Predicates its devices cite: 30 (10 its own); citations of its devices by later devices: 88 (10 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mitek Surgical Products, Inc.: 10 (https://510kreport.com/company/mitek-surgical-products)
- ETHICON, Inc.: 3 (https://510kreport.com/company/ethicon)
- Innovasive Devices, Inc.: 2 (https://510kreport.com/company/innovasive-devices)
- Linvatec Corp.: 2 (https://510kreport.com/company/linvatec)
- Encore Orthopedics, Inc.: 1 (https://510kreport.com/company/encore-orthopedics)
- Biocomposites, Ltd.: 1 (https://510kreport.com/company/biocomposites)
- Acufex Microsurgical, Inc.: 1 (https://510kreport.com/company/acufex-microsurgical)

## Firms that cite its devices most
- Depuy Mitek, A Johnson & Johnson Company: 29 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Mitek Worldwide: 10 (https://510kreport.com/company/mitek-worldwide)
- Depuy Mitek: 5 (https://510kreport.com/company/depuy-mitek)
- Core Essence Orthopaedics, LLC: 4 (https://510kreport.com/company/core-essence-orthopaedics)
- Sterilmed, Inc.: 3 (https://510kreport.com/company/sterilmed)
- Biomet Sports Medicine: 3 (https://510kreport.com/company/biomet-sports-medicine)
- Alliance Medical Corp.: 3 (https://510kreport.com/company/alliance-medical)
- Arthrocare Corp.: 2 (https://510kreport.com/company/arthrocare)

## Its most-cited devices
- K992487: Mitek Mini Quickanchor Plus (1999), cited by 8
- K974022: VAPR (1998), cited by 7
- K962511: Mitek Micro Anchor (1996), cited by 7
- K002639: Bioknotless Anchor (2001), cited by 6
- K013572: Mitek Biocryl Interference Screws (2002), cited by 6
- K982420: Mitek Micro Anchor (1998), cited by 6

## Recent decisions
- K013572: Mitek Biocryl Interference Screws (Mar 14, 2002)
- K013781: Rididfix 2.7MM BTB Cross Pin Kit (Feb 6, 2002)
- K002639: Bioknotless Anchor (May 11, 2001)
- K010633: Rigidfix Soft Tissue Acl Crosspin System (May 9, 2001)
- K002406: Mitek 2GII Meniscal Repair System (Feb 15, 2001)
- K003076: Mitek Cufftack (Oct 27, 2000)
- K002402: Vapr TC Electrode for Use with Vapr II Electrosurgical System (Aug 31, 2000)
- K002422: Varpr 3.5MM 90 Suction Electrode for Use with Vapr System (Aug 31, 2000)

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