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CarboFix Gains FDA Clearance for Carbon Fiber VBR -

CarboFix received FDA 510(k) clearance to market the CarboClear® Carbon Fiber Vertebral Body Replacement (VBR) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma. 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. (CarboFix, 10/17/19)