CarboFix Orthopedics Ltd. has won FDA approval for a spinal screw system for use in people with advanced spinal cancer.
The CarboClear carbon fiber pedicle screw system was designed to restore the integrity of the spinal column, even in the absence of fusion, for a limited time period in patients with advanced-stage thoracic and lumbar spine tumors. The screw system will hold the spine securely until patients are able to undergo spinal fusion, according to the Herzeliya, Israel-based company. The FDA gave the system 510(k) clearance.
CarboClear pedicle screws are made of continuous carbon fibers reinforced polymer (PEEK). The PEEK adheres the fibers together, and the continuous carbon fibers are layered in a unidirectional, longitudinal orientation, as well as in helical/diagonal orientation, according to the company’s website. The material makes the CarboFix implants radiolucent, which is beneficial during surgery and follow-up.
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