# Plus Orthopedics

- Location (FDA's records): San Diego, CA
- FDA decisions: 43 (1997–2007): 43 510(k) clearances
- Names in FDA's records: Plus Orthopedics (38); Plus Orthopedics AG (5)
- Product codes: LWJ (7), JWH (6), LZO (6), KRO (4), JDI (3), KTT (3), HAW (3), HSD (2), LPH (2), HRY (2), KWY (1), HWC (1)
- Predicates its devices cite: 62 (24 its own); citations of its devices by later devices: 113 (24 its own)
- Recalls linked to its devices: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Encore Orthopedics, Inc.: 7 (https://510kreport.com/company/encore-orthopedics)
- Sulzer Orthopedics, Inc.: 4 (https://510kreport.com/company/sulzer-orthopedics)
- Howmedica Corp.: 3 (https://510kreport.com/company/howmedica)
- Johnson & Johnson Professionals, Inc.: 3 (https://510kreport.com/company/johnson-johnson-professionals)
- Kinamed, Inc.: 2 (https://510kreport.com/company/kinamed)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)
- Aesculap, Inc.: 2 (https://510kreport.com/company/aesculap)
- Osteonics Corp.: 2 (https://510kreport.com/company/osteonics)

## Firms that cite its devices most
- Smith & Nephew, Inc.: 47 (https://510kreport.com/company/smith-nephew)
- Medacta International S.A.: 8 (https://510kreport.com/company/medacta-international)
- Aesculap, Inc.: 4 (https://510kreport.com/company/aesculap)
- Apex Surgical, LLC: 3 (https://510kreport.com/company/apex-surgical)
- Omni Life Science, Inc.: 3 (https://510kreport.com/company/omni-life-science)
- Lima-Lto S.P.A.: 3 (https://510kreport.com/company/lima-lto)
- Lima Corporate S.P.A.: 2 (https://510kreport.com/company/lima-corporate)
- Encore Medical L.P.: 2 (https://510kreport.com/company/encore-medical)

## Its most-cited devices
- K001942: SL-Plus and SLR-Plus Stems (2000), cited by 9
- K070278: Polarcup Dual Mobility System (2007), cited by 8
- K063578: Promos Modular Shoulder System (2007), cited by 6
- K061362: Pigalileo Total Knee Replacement (TKR) System (2006), cited by 6
- K982447: Plus Bipolar Prosthesis Cocrmo (1998), cited by 5
- K032126: Promos Shoulder (2004), cited by 5

## Recent decisions
- K070928: Ceramic  Ball Heads, 28, 32 and 36 MM (Aug 1, 2007)
- K070731: Pigalileo Total Hip Replacement (THR) System (Jul 31, 2007)
- K070278: Polarcup Dual Mobility System (Apr 16, 2007)
- K063578: Promos Modular Shoulder System (Mar 2, 2007)
- K061362: Pigalileo Total Knee Replacement (TKR) System (Oct 6, 2006)
- K032126: Promos Shoulder (Jan 8, 2004)
- K033763: Modification to Slim Gliding Nail System (Dec 18, 2003)
- K032709: Modular Plus Hip Stem (Sep 23, 2003)

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