# Consensus Orthopedics, Inc.

- Location (FDA's records): El Dorado Hills, CA
- FDA decisions: 17 (2010–2017): 17 510(k) clearances
- Product codes: LPH (7), JWH (5), MBH (2), HSX (1), OQG (1), LWJ (1)
- 510(k) review time since 2016: median 268 days, against 118 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 122 (19 its own); citations of its devices by later devices: 35 (19 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.: 41 (https://510kreport.com/company/us-medical-products)
- Hayes Medical, Inc.: 31 (https://510kreport.com/company/hayes-medical)
- Biomet, Inc.: 6 (https://510kreport.com/company/biomet)
- Zimmer, Inc.: 6 (https://510kreport.com/company/zimmer)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Smith & Nephew Richards, Inc.: 2 (https://510kreport.com/company/smith-nephew-richards)
- Aesculap Implant Systems, LLC: 2 (https://510kreport.com/company/aesculap-implant-systems)

## Firms that cite its devices most
- Tgm Medical, Inc.: 5 (https://510kreport.com/company/tgm-medical)
- Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics: 3 (https://510kreport.com/company/shalby-advanced-technologies-dba-consensus-orthopedics)
- Omni Life Science, Inc.: 2 (https://510kreport.com/company/omni-life-science)
- Theken Companies, LLC: 2 (https://510kreport.com/company/theken-companies)
- Global Manufacturing Technology: 1 (https://510kreport.com/company/global-manufacturing-technology)
- Shalby Advanced Technologies: 1 (https://510kreport.com/company/shalby-advanced-technologies)
- Optimotion Implants, LLC: 1 (https://510kreport.com/company/optimotion-implants)
- Permedica: 1 (https://510kreport.com/company/permedica)

## Its most-cited devices
- K110950: Consensus Knee System (2011), cited by 8
- K102399: Consensus Taperset Hip System (2010), cited by 7
- K100933: Consensus CS2 Plus Acetabular Insert (2010), cited by 5
- K100542: Consensus Revision Knee System (2010), cited by 5
- K141043: CS2 Multi-Hole Acetabular Shell (2014), cited by 2
- K133919: Consensus Vitalite Tibial Insert (2014), cited by 2

## Recent decisions
- K170344: Tahoe Uni Knee System (Oct 5, 2017)
- K163167: CKS Plus Knee System (Aug 9, 2017)
- K160515: PS2 Knee System (Dec 19, 2016)
- K143725: Consensus Knee System Modular Tibial Baseplate (Mar 4, 2015)
- K133919: Consensus Vitalite Tibial Insert (Jul 14, 2014)
- K141043: CS2 Multi-Hole Acetabular Shell (May 19, 2014)
- K130652: Vitalite E Cross-Linked Polyethylene Acetabular Insert (Dec 17, 2013)
- K122512: CS2 Hip System (Nov 5, 2012)

Source page: https://510kreport.com/company/consensus-orthopedics