# Synthes

- Location (FDA's records): West Chester, PA
- FDA decisions: 26 (1998–2026): 26 510(k) clearances
- Names in FDA's records: Synthes (11); Synthes, Inc. (8); Synthes GmbH (7)
- Product codes: HRS (8), JEY (4), GXQ (2), MNI (1), KKY (1), MQP (1), KWQ (1), MQV (1), MQN (1), NDN (1), KCT (1), GWO (1)
- 510(k) review time since 2016: median 146 days, against 96 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 65 (2 its own); citations of its devices by later devices: 57 (2 its own)
- Recalls linked to its devices: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 38 (https://510kreport.com/company/synthes-usa)
- DePuy Synthes: 4 (https://510kreport.com/company/depuy-synthes)
- Bio-Vascular, Inc.: 3 (https://510kreport.com/company/bio-vascular)
- Osteomed LP: 2 (https://510kreport.com/company/osteomed)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Ceremed, Inc.: 1 (https://510kreport.com/company/ceremed)
- Depuyacromed: 1 (https://510kreport.com/company/depuyacromed)
- Depuy Motech Acromed: 1 (https://510kreport.com/company/depuy-motech-acromed)

## Firms that cite its devices most
- Synthes (USA) Products, LLC: 12 (https://510kreport.com/company/synthes-usa-products)
- Synthes (Usa): 5 (https://510kreport.com/company/synthes-usa)
- Synthes Spine: 4 (https://510kreport.com/company/synthes-spine)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Theken Surgical,Llc: 2 (https://510kreport.com/company/theken-surgical)
- Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.: 2 (https://510kreport.com/company/synthes-usa-products-depuy-orthopaedics)
- Aesculap Implant System, Inc.: 1 (https://510kreport.com/company/aesculap-implant-system)
- Depuy Mitek: 1 (https://510kreport.com/company/depuy-mitek)

## Its most-cited devices
- K003836: Synthes Synex Spacer System (2001), cited by 9
- K982732: Synthes (Usa) Distal Radius Plate System (DRPS) (1998), cited by 9
- K093772: Synthes Sternal Fixation System (2010), cited by 6
- K013072: Chronos Tricalcium Prosphate (Chronos TCP) (2002), cited by 6
- K020602: Synthes Pilon Plate (2002), cited by 4
- K010108: Uss-Line Extension (2001), cited by 3

## Recent decisions
- K254093: DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (Mar 10, 2026)
- K260069: DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (Mar 9, 2026)
- K254054: VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (Mar 2, 2026)
- K243715: Synthes Patient Specific Implants (Nov 12, 2025)
- K241927: Synthes Graphic Case & Tray System (Mar 28, 2025)
- K233994: VOLT™ Proximal Humerus 3.5 Plating System (Jul 26, 2024)
- K233967: DePuy Synthes MatrixSTERNUM Fixation System (May 9, 2024)
- K131792: Synthecel Dura Repair, Synthecel Dura Onlay (Dec 16, 2013)

Source page: https://510kreport.com/company/synthes