# Synthes (USA) Products, LLC

- Location (FDA's records): West Chester, PA
- FDA decisions: 61 (2010–2026): 61 510(k) clearances
- Names in FDA's records: Synthes (USA) Products, LLC (45); Synthes USA Products, LLC (16)
- Product codes: HRS (15), HSB (6), HWC (5), MAX (4), MQN (3), KTT (3), JEY (3), JDR (2), KWP (2), OVD (2), MTJ (1), MQV (1)
- 510(k) review time since 2016: median 106 days, against 107 for FDA's reviews in the same codes and years (10 of 25 faster)
- Predicates its devices cite: 218 (18 its own); citations of its devices by later devices: 171 (18 its own)
- Recalls linked to its devices: 39 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 129 (https://510kreport.com/company/synthes-usa)
- Synthes: 12 (https://510kreport.com/company/synthes)
- Synthes Spine: 9 (https://510kreport.com/company/synthes-spine)
- Seaspine, Inc.: 3 (https://510kreport.com/company/seaspine)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Interpore Cross Intl.: 2 (https://510kreport.com/company/interpore-cross-intl)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- DePuy Synthes: 2 (https://510kreport.com/company/depuy-synthes)

## Firms that cite its devices most
- Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.: 13 (https://510kreport.com/company/synthes-usa-products-depuy-orthopaedics)
- DePuy Synthes: 7 (https://510kreport.com/company/depuy-synthes)
- Globus Medical, Inc.: 7 (https://510kreport.com/company/globus-medical)
- Medacta International S.A.: 6 (https://510kreport.com/company/medacta-international)
- Stryker Corp.: 5 (https://510kreport.com/company/stryker)
- Newclip Technics: 4 (https://510kreport.com/company/newclip-technics)
- Medos International SARL: 4 (https://510kreport.com/company/medos-international)
- Tdm Co., Ltd.: 4 (https://510kreport.com/company/tdm)

## Its most-cited devices
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System (2015), cited by 32
- K112583: Synthes Cortical Screws (2011), cited by 28
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw (2017), cited by 18
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System (2012), cited by 8
- K141796: Depuy Synthes Tomofix Osteotomy System (2014), cited by 7
- K150099: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) (2015), cited by 6

## Recent decisions
- K254087: MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (Jun 11, 2026)
- K212943: SyntheCel Dura Repair (Jan 28, 2022)
- K211313: MAXFRAME Multi-Axial Correction System (aka MAXFRAME) (May 25, 2021)
- K210408: DePuy Synthes Variable Angle Locking Patella Plating System (Apr 8, 2021)
- K210205: DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System (Mar 26, 2021)
- K201346: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm (Sep 23, 2020)
- K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (Sep 18, 2020)
- K201944: DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) (Sep 10, 2020)

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