Synthes 4.0 and 5.0 mm Locking Screws

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

510(k) Number

K000089 ↗

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) →

• Are these locking screws reusable or intended for single-use in orthopedic procedures?

  These Synthes 4.0 and 5.0 mm Locking Screws are explicitly designed for single-use only in orthopedic procedures. The manufacturer’s description confirms they are supplied sterile, which aligns with single-use medical devices to prevent cross-contamination and ensure patient safety.

• What sizes are available for these locking screws, and how do they differ in clinical use?

  The device is available in two sizes: 4.0 mm and 5.0 mm. The size selection depends on the clinical requirement, such as the diameter of the bone or the specific fixation needs for fractures or joint reconstructions in long bones. The 4.0 mm size may be used for smaller bones or less demanding stabilization, while the 5.0 mm size offers additional strength for larger or more complex cases.

• How are these screws supplied, and what does the sterility guarantee entail?

  The screws are supplied sterile by the manufacturer, ensuring they meet medical-grade cleanliness standards for direct implantation. Sterility is critical for orthopedic procedures to prevent infection, and the single-use designation further supports this by preventing reuse, which could compromise sterility.

• What regulatory pathway was followed for FDA clearance, and what does ‘Substantially Equivalent’ mean in this context?

  These screws were cleared via the FDA’s 510(k) Traditional pathway under Product Code HWC (Orthopedic) and were determined to be Substantially Equivalent (SESE) to a legally marketed predicate device. This classification means the FDA concluded the device has the same intended use and technological characteristics as the predicate, ensuring it meets safety and effectiveness standards without requiring a full premarket approval.