DePuy Synthes Trauma Screws

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K192745 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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

  Class II

  FDA 510(k) K160553 Active Cleared 30 Jun 2017

• DePuy Synthes Sterilization Container System

  Class II

  FDA 510(k) K181933 Active Cleared 9 May 2019

• 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

  Class II

  FDA 510(k) K172975 Active Cleared 21 Jun 2018

• DePuy Synthes Trauma Orthopedic Plates and Screws

  Class II

  FDA 510(k) K180310 Active Cleared 1 Nov 2018