Synthes 1.0mm Ti. Cortex, Self-Drilling Screws (Hand & Neuro)

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

510(k) Number

K050607 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

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 are the Synthes 1.0mm Titanium Cortex Self-Drilling Screws used for?

  These screws are orthopedic fixation devices designed specifically for internal stabilization of bone fractures in hand and neurosurgical procedures. Their self-drilling feature eliminates the need for separate drilling, streamlining insertion and minimizing bone trauma during surgery.

• Are these screws sterile and single-use?

  Yes, the Synthes 1.0mm Titanium Cortex Self-Drilling Screws are supplied sterile and intended for single-use only. This ensures patient safety and maintains device integrity, as reuse could compromise sterility and performance.

• What material are these screws made from, and why?

  The screws are manufactured from titanium alloy, which provides excellent biocompatibility and corrosion resistance. This material choice reduces the risk of adverse reactions in patients and ensures long-term stability in the body.

• How should these screws be stored and handled?

  Storage and handling must follow sterile medical device protocols to preserve their integrity before use. Since they are sterile and single-use, they should be kept in a sealed, uncontaminated environment until opened for surgical use.

• What regulatory clearance does this device have?

  The Synthes 1.0mm Titanium Cortex Self-Drilling Screws hold FDA 510(k) clearance under the classification of orthopedic fixation devices, specifically for hand and neurosurgical applications. The clearance (K050607) was granted under traditional review standards.