# Depuy Mitek, Inc., A Johnson and Johnson Company

- Location (FDA's records): Raynham, MA
- FDA decisions: 6 (2012–2015): 6 510(k) clearances
- Names in FDA's records: Depuy Mitek, Inc., A Johnson and Johnson Company (3); Depuy Mitek, A Johnson and Johnson Company (3)
- Product codes: MBI (3), MAI (2), NEW (1)
- Predicates its devices cite: 19 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 5 (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: 8 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- Depuy Mitek: 2 (https://510kreport.com/company/depuy-mitek)
- ETHICON, Inc.: 2 (https://510kreport.com/company/ethicon)
- Biomet Sports Medicine: 1 (https://510kreport.com/company/biomet-sports-medicine)
- Biomet Manufacturing Corp: 1 (https://510kreport.com/company/biomet-manufacturing)
- Innovasive Devices, Inc.: 1 (https://510kreport.com/company/innovasive-devices)
- Johnson & Johnson: 1 (https://510kreport.com/company/johnson-johnson)

## Firms that cite its devices most
- Medos International SARL: 2 (https://510kreport.com/company/medos-international)
- Depuy Mitek, A Johnson & Johnson Company: 1 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)

## Its most-cited devices
- K131683: Healix Advance Knotless Peek Anchor (6.5MM) (2013), cited by 2
- K122123: 6-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw 8-10MM X 30 MM Intrafix Peek Tapered (2012), cited by 1

## Recent decisions
- K150209: Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc (Oct 6, 2015)
- K140643: Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot Technology (Jul 8, 2014)
- K140324: Rigidloop Adjustable Cortical Implant: Standard, Long and XL (Jul 7, 2014)
- K131683: Healix Advance Knotless Peek Anchor (6.5MM) (Jun 27, 2013)
- K123668: Orthocord (Feb 26, 2013)
- K122123: 6-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw 8-10MM X 30 MM Intrafix Peek Tapered (Oct 2, 2012)

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