Titanium Tube to Tube Clamp

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

510(k) Number

K960782 ↗

FDA Product Code

JEC

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 primary use of the Titanium Tube-to-Tube Clamp in orthopedic surgery?

  The Titanium Tube-to-Tube Clamp is designed to secure and connect two tubular components, such as carbon fiber rods or stainless steel tubes, within external fixation systems. It provides stable fixation for orthopedic applications, particularly in the treatment of long bone fractures requiring external stabilization.

• Is the Titanium Tube-to-Tube Clamp intended for single-use or reusable applications?

  The device is explicitly supplied as a reusable clamp, meaning it is engineered for repeated use in orthopedic surgical settings after proper cleaning and maintenance.

• What material is the clamp made from, and why is this significant?

  The clamp is manufactured from titanium, which ensures durability and compatibility with external fixation frames. Titanium is chosen for its strength, lightweight properties, and resistance to corrosion, making it ideal for invasive orthopedic applications.

• How is the regulatory status of this clamp determined, and what does that mean for its use?

  The clamp is regulated under the FDA’s 510(k) clearance process (K960782) and classified as a Class II device with special controls. This means it has undergone a review to demonstrate substantial equivalence to a predicate device and meets additional regulatory standards for invasive orthopedic components, ensuring its safety and effectiveness for intended use.

• Are there any specific storage requirements mentioned for the Titanium Tube-to-Tube Clamp?

  The provided data does not specify any particular storage requirements for the clamp, such as temperature or environmental conditions. However, as a reusable device, it should be stored in a clean, dry environment to prevent contamination and ensure longevity.