# United Orthopedic Corporation

- Location (FDA's records): Hsinchu, TW
- FDA decisions: 61 (2000–2026): 61 510(k) clearances
- Names in FDA's records: United Orthopedic Corporation (41); United Orthopedic Corp. (20)
- Product codes: JWH (20), LPH (15), LZO (11), MBH (4), KWY (3), KRO (2), LWJ (2), MEH (2), OQI (1), JDI (1)
- 510(k) review time since 2016: median 244 days, against 118 for FDA's reviews in the same codes and years (9 of 25 faster)
- Predicates its devices cite: 216 (122 its own); citations of its devices by later devices: 140 (122 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomet, Inc.: 17 (https://510kreport.com/company/biomet)
- Zimmer, Inc.: 17 (https://510kreport.com/company/zimmer)
- Smith & Nephew, Inc.: 16 (https://510kreport.com/company/smith-nephew)
- Howmedica Osteonics Corp.: 7 (https://510kreport.com/company/howmedica-osteonics)
- Osteonics Corp.: 6 (https://510kreport.com/company/osteonics)
- DePuy Orthopaedics, Inc.: 4 (https://510kreport.com/company/depuy-orthopaedics)
- Corin USA: 4 (https://510kreport.com/company/corin-usa)
- Wrightmedicaltechnologyinc: 3 (https://510kreport.com/company/wrightmedicaltechnologyinc)

## Firms that cite its devices most
- Responsive Orthopedics, LLC: 4 (https://510kreport.com/company/responsive-orthopedics)
- Medacta International S.A.: 2 (https://510kreport.com/company/medacta-international)
- Cpm Medical Consultants, LLC: 2 (https://510kreport.com/company/cpm-medical-consultants)
- Novosource, Inc.: 2 (https://510kreport.com/company/novosource)
- Waldemar Link GmbH & Co. KG: 1 (https://510kreport.com/company/waldemar-link)
- Surgtech, Inc.: 1 (https://510kreport.com/company/surgtech)
- The Progressive Orthopaedic Company, LLC: 1 (https://510kreport.com/company/progressive-orthopaedic)
- Corin USA: 1 (https://510kreport.com/company/corin-usa)

## Its most-cited devices
- K051640: U2 Total Knee System (2006), cited by 16
- K082424: United U2 Total Knee System (2008), cited by 9
- K050262: U2 Acetabular Component (2005), cited by 9
- K111546: U2 Hip System (2011), cited by 7
- K994078: U1 Hip System (2000), cited by 7
- K122185: U-Motion II Acetabular System (2013), cited by 6

## Recent decisions
- K253948: Momentum Acetabular Cup System (Sep 2, 2026)
- K252725: Stem Extension Line (U2 Total Knee System—PSA Type) (Sep 25, 2025)
- K252303: Stem Extension Line (USTAR II System) (Aug 22, 2025)
- K243656: U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (Jul 31, 2025)
- K242315: Resolve Modular Revision Hip Stem (May 1, 2025)
- K243466: Conformity Stem Extension Line, #0 (Jan 6, 2025)
- K243024: Cellbrick Knee Spacer (Dec 20, 2024)
- K242249: Conformity Stem Extension Line (Aug 30, 2024)

Source page: https://510kreport.com/company/united-orthopedic