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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K161616 ↗

FDA Product Code

HWC

FDA applicant

Synthes USA Products, LLC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K254087 Active Cleared 11 Jun 2026

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  Class II

  FDA 510(k) K141796 Active Cleared 29 Aug 2014

• USS System

  Class II

  FDA 510(k) K170654 Active Cleared 29 Mar 2017

• MatrixRIB Fixation System

  Class II

  FDA 510(k) K133616 Active Cleared 2 May 2014

• Synthes Ria System (Expanded Indications) Open recall

  Class I

  FDA 510(k) K111437 Active Cleared 10 Aug 2011

• DePuy Synthes 2.0 mm Quick Insertion Screws

  Class II

  FDA 510(k) K180541 Active Cleared 21 Nov 2018

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