CarboFix Spine Screw Systems Cleared by FDA

CarboFix’s CarboClear carbon fiber pedicle screw system was granted 510(k) clearance by the FDA for three different sized screws.

The three screw types, which come in diameters of 5.5, 6.5 and 7.5 mms and lengths of 30-45 and 35-55 mms, are marked by an ultrathin titanium shell to allow visualization with a fluoroscope.

The device can be used temporarily in patients with advanced stage thoracic and lumbar spine tumors who cannot undergo fusion.