Fortross Bone Void Filler

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

510(k) Number

K110561 ↗

FDA product code

MQV

Device class

Class II

Regulation

21 CFR Part 888.3045

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 Fortross Bone Void Filler used for?

  Fortross Bone Void Filler is a scaffold designed for the in-growth of new bone and connective tissues. It serves as a bone graft substitute specifically for orthopedic applications where superior bone regeneration is desired in bone void filling procedures.

• How is Fortross Bone Void Filler supplied?

  Fortross Bone Void Filler is supplied as a device specifically for orthopedic use. It is marketed by Pioneer Surgical Technology and comes ready for use in bone void filling applications without requiring additional preparation steps.

• What regulatory approval does Fortross Bone Void Filler have?

  Fortross Bone Void Filler has received FDA 510(k) clearance with the number K110561. This clearance was granted on April 29, 2011, after being received on February 28, 2011, and was determined to be substantially equivalent to other devices in its product code category MQV.

• Is Fortross Bone Void Filler single-use or reusable?

  The device data does not specify whether Fortross Bone Void Filler is single-use or reusable. Clinicians should consult the manufacturer's instructions for use or contact Pioneer Surgical Technology directly for specific information regarding the intended use and disposal protocol of this device.