CarboFix Gains FDA Clearance for Pedicle Screw

By Julie A. Vetalice

CarboFix Orthopedics received FDA 510(k) clearance to market the CarboClear® Carbon Fiber Pedicle Screw to treat oncological patients. CarboClear is intended to stabilize the spinal column in the absence of fusion for a limited time period in patients with advanced-stage in the thoracic and lumbar spine.

Reported benefits of CarboClear include no backscattering, which allows the use of radiation therapy without harming the healthy surrounding tissue; minimal attenuation of External Beam Radiation, allowing radiation to pass through the implant with almost no reduction in the radiation dose level; and no artifact in CT.

Source: CarboFix Orthopedics Ltd.


Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory