CarboFix Gains FDA Clearance for Carbon Fiber VBR

By Julie A. Vetalice

CarboFix received FDA 510(k) clearance to market the CarboClear® Carbon Fiber Vertebral Body Replacement (VBR) system to replace collapsed, damaged or unstable vertebral bodies following tumor or trauma.

CarboClear VBR joins the CarboClear Pedicle Screw and CarboClear Fenestrated Pedicle Screw, previously FDA-cleared. Official product launch will commence later this month.

The device is a carbon fiber-based implant with integrated porous Ti-alloy endplates. Potential advantages of carbon fiber devices include enhanced radiation therapy planning abilities and enhanced follow-up abilities due to artifacts-free imaging. Further, optimized fatigue strength supports patients with impaired healing processes. The VBR is intended for use with supplemental fixation and optional allograft or autograft.

Source: CarboFix

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory