Synthes 3.9 mm Pelvic Screws

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K013044 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

See all devices from Synthes (Usa) →

• What is the Synthes 3.9 mm Pelvic Screw used for?

  The Synthes 3.9 mm Pelvic Screw is intended for use in orthopedic procedures involving pelvic stabilization, specifically for the stabilization of pelvic fractures and during periacetabular osteotomy procedures, as it is a bone screw designed for fixation in these clinical settings.

• How is the Synthes 3.9 mm Pelvic Screw supplied and is it reusable?

  The device is supplied as a sterile, single-use implant, meaning it is provided in a sterile condition for one-time use during surgery and is not designed or intended for reuse after implantation.

• What are the key physical characteristics of the Synthes 3.9 mm Pelvic Screw?

  The Synthes 3.9 mm Pelvic Screw is a machined metallic bone fixation fastener with a 3.9 mm diameter and features a hex drive head, which allows for secure engagement with surgical instruments during implantation.