# DePuy Synthes

- Location (FDA's records): West Chester, PA
- FDA decisions: 20 (1979–2024): 20 510(k) clearances
- Names in FDA's records: DePuy Synthes (19); Depuy Synthes, Inc. (1)
- Product codes: HRS (10), OLO (3), KTT (2), NKG (1), HSB (1), KWQ (1), JDP (1), KWI (1)
- 510(k) review time since 2016: median 89 days, against 90 for FDA's reviews in the same codes and years (10 of 16 faster)
- Predicates its devices cite: 95 (3 its own); citations of its devices by later devices: 44 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 73 (https://510kreport.com/company/synthes-usa)
- Synthes (USA) Products, LLC: 7 (https://510kreport.com/company/synthes-usa-products)
- Medos International SARL: 5 (https://510kreport.com/company/medos-international)
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)
- Stryker Leibinger GmbH & Co KG: 1 (https://510kreport.com/company/stryker-leibinger)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Biomet Microfixation: 1 (https://510kreport.com/company/biomet-microfixation)
- Orthospin: 1 (https://510kreport.com/company/orthospin)

## Firms that cite its devices most
- Medos International SARL: 6 (https://510kreport.com/company/medos-international)
- Synthes: 4 (https://510kreport.com/company/synthes)
- Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/synthes-usa-products-depuy-orthopaedics)
- Spineart: 2 (https://510kreport.com/company/spineart)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.): 2 (https://510kreport.com/company/pioneer-surgical-technology-dba-rti-surgical)
- Synthes (USA) Products, LLC: 2 (https://510kreport.com/company/synthes-usa-products)
- BAAT Medical Products B.V.: 1 (https://510kreport.com/company/baat-medical-products)

## Its most-cited devices
- K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System (2015), cited by 11
- K792352: Synthes Cervical Vertabrae Plates (1979), cited by 7
- K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System (2024), cited by 4
- K162124: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins (2017), cited by 4
- K190409: MatrixRIB Fixation System (2019), cited by 3
- K221809: DePuy Synthes 3.5mm Intrapelvic Acetabular System (2022), cited by 2

## Recent decisions
- K233696: DePuy Synthes Retrograde Femoral Nail Advanced System (Aug 1, 2024)
- K233256: Robotic Integration Instruments (Jun 17, 2024)
- K233255: CROSSNAV Navigation Enabled Instruments (Jun 17, 2024)
- K233254: TELIGEN System Navigation Ready Instruments (Jun 14, 2024)
- K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System (Mar 21, 2024)
- K231922: DEPUY SYNTHES MAXFRAME AUTOSTRUT System (Jul 26, 2023)
- K221809: DePuy Synthes 3.5mm Intrapelvic Acetabular System (Sep 20, 2022)
- K213563: DePuy Synthes Radial Head Replacement System (Mar 18, 2022)

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