Icotec Earns FDA Clearance for Pedicle Screw System

The FDA granted Swiss devicemaker Icotec 510(k) clearance for its VADERone pedicle screw system, used for minimally-invasive and open spine surgeries.

The device uses the company’s BlackArmor carbon/PEEK composite material, a carbon fiber interwoven 3D fiber architecture to secure stabilization and visualization after the operation, an important aspect of spinal tumor procedures.

The nonmetallic screw system provides strength and radiolucency. The system’s X-ray, CT and MRI translucency makes a significant difference during surgery and in postoperative assessments.