# Synthes (Usa)

- Location (FDA's records): Paoli, PA
- FDA decisions: 419 (1977–2018): 418 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Synthes (Usa) (403); Synthes USA (9); Synthes (Usa), LLC (5); Synthes USA, LLC (2)
- Product codes: HRS (95), JEY (38), KTT (32), HWC (31), HSB (23), KWP (17), LXT (14), DZL (13), KWQ (13), MQN (12), JDS (11), JDQ (8)
- Predicates its devices cite: 217 (134 its own); citations of its devices by later devices: 2,232 (134 its own)
- Recalls linked to its devices: 206 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes Spine: 10 (https://510kreport.com/company/synthes-spine)
- Zimmer, Inc.: 7 (https://510kreport.com/company/zimmer)
- Biomet, Inc.: 6 (https://510kreport.com/company/biomet)
- Smith & Nephew, Inc.: 6 (https://510kreport.com/company/smith-nephew)
- Synthes: 5 (https://510kreport.com/company/synthes)
- Geny Medical, Inc.: 3 (https://510kreport.com/company/geny-medical)
- Synthes (USA) Products, LLC: 3 (https://510kreport.com/company/synthes-usa-products)
- Poly-Medics,Inc.: 3 (https://510kreport.com/company/poly-medics)

## Firms that cite its devices most
- Synthes (USA) Products, LLC: 129 (https://510kreport.com/company/synthes-usa-products)
- Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.: 83 (https://510kreport.com/company/synthes-usa-products-depuy-orthopaedics)
- DePuy Synthes: 73 (https://510kreport.com/company/depuy-synthes)
- Synthes Spine: 71 (https://510kreport.com/company/synthes-spine)
- Emerge Medical: 44 (https://510kreport.com/company/emerge-medical)
- Medartis AG: 41 (https://510kreport.com/company/medartis)
- Globus Medical, Inc.: 39 (https://510kreport.com/company/globus-medical)
- Aap Implantate AG: 38 (https://510kreport.com/company/aap-implantate)

## Its most-cited devices
- K000684: Small Fragment Dynamic Compression Locking (DCL) System (2000), cited by 69
- K021932: Synthes 6.5 MM Cannulated Screw (2002), cited by 62
- K011335: Synths One-Third Tubular DCL Plate (2001), cited by 43
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications (2008), cited by 43
- K030866: Synthes Anterior CSLP System (2003), cited by 42
- K063049: Synthes (Usa) Modular Mini Fragment LCP System (2006), cited by 40

## Recent decisions
- K180821: TruMatch Graft Cage - Long Bone (Dec 21, 2018)
- K161417: DePuy Synthes MAXFRAME Multi-Axial Correction System (Nov 10, 2016)
- K152239: Zero-P Natural Plate System (Dec 2, 2015)
- K141527: Depuy Synthes Variable Angle Locking Hand System (Mar 30, 2015)
- K131984: Synthes Synsonic Ulna Nail (Mar 31, 2014)
- K130146: Synthes Synflate Vertevral Balloon System (May 20, 2013)
- K121601: Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate (Jul 6, 2012)
- K112030: Synthes Radial Head Prosthesis System (Jun 19, 2012)

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