DePuy Synthes Trauma Orthopedic Plates and Screws— 510(k) K180310

Clearance details

Applicant

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

Product code

Product code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2018-02-05

Decision date

2018-11-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Chester, PA, US

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• K192745 — DePuy Synthes Trauma Screws2019-11-26
• K181933 — DePuy Synthes Sterilization Container System2019-05-09
• 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 Conditional2018-06-21
• 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 S2017-06-30

Death

27

Injury

10,340

Malfunction

3,328

Total

13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →