# Hayes Medical, Inc.

- Location (FDA's records): El Dorado Hills, CA
- FDA decisions: 12 (1995–2007): 12 510(k) clearances
- Product codes: LWJ (3), LPH (3), LZO (2), JWH (2), HWC (1), KWL (1)
- Predicates its devices cite: 14 (2 its own); citations of its devices by later devices: 43 (2 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
- U.S. Medical Products, Inc.: 4 (https://510kreport.com/company/us-medical-products)
- Howmedica Osteonics Corp.: 1 (https://510kreport.com/company/howmedica-osteonics)
- Biomet Orthopedics, Inc.: 1 (https://510kreport.com/company/biomet-orthopedics)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Apex Surgical, LLC: 1 (https://510kreport.com/company/apex-surgical)
- Orthopedic Source, Inc.: 1 (https://510kreport.com/company/orthopedic-source)
- Encore Orthopedics, Inc.: 1 (https://510kreport.com/company/encore-orthopedics)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)

## Firms that cite its devices most
- Consensus Orthopedics, Inc.: 31 (https://510kreport.com/company/consensus-orthopedics)
- Tgm Medical, Inc.: 3 (https://510kreport.com/company/tgm-medical)
- Aesculap Implant Systems, LLC: 2 (https://510kreport.com/company/aesculap-implant-systems)
- Imaging Therapeutics, Inc.: 1 (https://510kreport.com/company/imaging-therapeutics)
- Pipeline Orthopedics: 1 (https://510kreport.com/company/pipeline-orthopedics)
- Shalby Advanced Technologies: 1 (https://510kreport.com/company/shalby-advanced-technologies)
- Omnlife Science: 1 (https://510kreport.com/company/omnlife-science)
- Ortho Development Corp.: 1 (https://510kreport.com/company/ortho-development)

## Its most-cited devices
- K001456: Consensus Knee System (2000), cited by 7
- K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert (2007), cited by 7
- K060635: Consensus Acetabular Shell System (2006), cited by 6
- K021466: Consensus Acetabular Insert, Cross-Linked Polyethylene (2002), cited by 6
- K020153: Consensus Acetablar Shell, TI Coated (2002), cited by 4
- K953198: Corticellous Bone Screw (1995), cited by 3

## Recent decisions
- K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert (Jan 31, 2007)
- K062383: Unisyn HA Plasma Modular Hip (Dec 21, 2006)
- K060635: Consensus Acetabular Shell System (Apr 28, 2006)
- K030151: Consensus Hip System, Unisyn Hip System (Apr 10, 2003)
- K030205: Consensus Unipolar Head, Cocr (Apr 1, 2003)
- K021466: Consensus Acetabular Insert, Cross-Linked Polyethylene (Jul 24, 2002)
- K020153: Consensus Acetablar Shell, TI Coated (Apr 15, 2002)
- K003649: Triton Hip System (Feb 23, 2001)

Source page: https://510kreport.com/company/hayes-medical