Bone Plate With Cables

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

510(k) Number

K972223 ↗

FDA product code

HRS

Device class

Class II

Regulation

21 CFR Part 888.3030

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

• Pacp

  Class II

  FDA 510(k) K083663 Active Cleared 25 Feb 2009

• Modification to: Pioneer Surgical Technology Quantum Spinal System

  Class II

  FDA 510(k) K070551 Active Cleared 29 Mar 2007

• Tritium Sternal Cable Plate System

  Class II

  FDA 510(k) K193468 Active Cleared 12 Mar 2020

• Pioneer Vertebral Spacer (Vertebral Spacer)

  Class II

  FDA 510(k) K061151 Active Cleared 24 Jul 2006

• Quantum/ Streamline Spinal System Model 02-Series and 10-Series

  Class II

  FDA 510(k) K093692 Active Cleared 11 Aug 2010

• Quantum/Streamline Tl Mis Spinal System

  Class II

  FDA 510(k) K093771 Active Cleared 10 Aug 2010

See all devices from Pioneer Surgical Technology, Inc. →

• What is the Bone Plate With Cables used for?

  The Bone Plate With Cables is a surgical fixation system specifically designed for the treatment of long bone fractures. It utilizes a combination of a bone plate with transverse holes, multifilament cables, and crimps to stabilize the bone during the healing process.

• How is the Bone Plate With Cables applied to the bone?

  During the surgical procedure, the multifilament cable is passed through the plate hole and around the bone. It is then secured with a crimp and tightened using a specialized tensioning device to apply the necessary compression to the fracture site.

• What is the regulatory status of this fixation system?

  The Bone Plate With Cables has received FDA 510(k) clearance under the K972223 submission. This indicates that the device has been found to be substantially equivalent to other legally marketed devices within the orthopedic product category.