# Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

- Location (FDA's records): West Chester, PA
- FDA decisions: 5 (2017–2019): 5 510(k) clearances
- Product codes: HRS (2), KCT (1), HWC (1), JDQ (1)
- 510(k) review time since 2016: median 269 days, against 116 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 101 (0 its own); citations of its devices by later devices: 6 (0 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
- Synthes (Usa): 83 (https://510kreport.com/company/synthes-usa)
- Synthes (USA) Products, LLC: 13 (https://510kreport.com/company/synthes-usa-products)
- DePuy Synthes: 3 (https://510kreport.com/company/depuy-synthes)
- Synthes: 2 (https://510kreport.com/company/synthes)

## Firms that cite its devices most
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- TriMed, Inc.: 1 (https://510kreport.com/company/trimed)
- Tdm Co., Ltd.: 1 (https://510kreport.com/company/tdm)

## Its most-cited devices
- K180310: DePuy Synthes Trauma Orthopedic Plates and Screws (2018), cited by 3
- K192745: DePuy Synthes Trauma Screws (2019), cited by 2
- K172975: DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional (2018), cited by 1

## Recent decisions
- K192745: DePuy Synthes Trauma Screws (Nov 26, 2019)
- K181933: DePuy Synthes Sterilization Container System (May 9, 2019)
- K180310: DePuy Synthes Trauma Orthopedic Plates and Screws (Nov 1, 2018)
- K172975: DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional (Jun 21, 2018)
- K160553: DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S (Jun 30, 2017)

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