Orthopaedic Cable System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K842977 ↗

FDA Product Code

JDQ

Device Class

Class II

Regulation

21 CFR Part 888.3010

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• Is the Orthopaedic Cable System intended for single-use or can it be reused in multiple procedures?

  The Orthopaedic Cable System is designed as a reusable device, meaning it is intended for use in multiple procedures after proper cleaning and sterilization. Since it is supplied in a non-sterile state, it must be sterilized before each use in a sterile operating environment.

• What types of bone fractures or orthopaedic procedures is this cable system primarily used for?

  The Orthopaedic Cable System is classified as a Cerclage, Fixation device and is specifically designed for internal fixation of bone fractures. It provides tensile strength and stability by securing bone fragments or implants together during orthopaedic surgical procedures, such as long bone fractures or joint stabilization.

• How is the Orthopaedic Cable System regulated by the FDA, and what does that mean for purchasing or clinical use?

  The Orthopaedic Cable System received FDA 510(k) clearance (K842977) under the Traditional pathway, with a decision of Substantially Equivalent (SESE). This means it was determined to be as safe and effective as a legally marketed device already on the market. Clinically, this clearance confirms the device meets FDA standards for internal fixation applications, but it does not imply any specific clinical indication—only that it adheres to regulatory requirements for orthopaedic fixation systems.

• What storage conditions should be followed for the Orthopaedic Cable System before use?

  Since the system is non-sterile and reusable, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, it must undergo sterilization in a sterile operating environment to ensure safety and efficacy during orthopaedic procedures. Follow manufacturer guidelines for cleaning and sterilization protocols.