icotec Gains FDA Clearance for VADER Pedicle System

By Julie A. Vetalice

icotec Gains FDA Clearance for VADER Pedicle System

icotec received FDA 510(k) clearance to market the VADER® Pedicle System for use with or without bone cement.

VADER is intended to restore spinal integrity, even in the absence of fusion, for a limited time period in patients with advanced-stage tumors in the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit fusion.

The screw's fenestration allows for bone cement augmentation to increase stability in patients with compromised bone.

"We are so proud to present today the VADER® product family which represents our continued commitment to develop and commercialize spinal implants made from our radiotransparent, nonmetallic BlackArmor® material that produces minimal image artifact while eliminating shielding and scattering of radiation during oncology treatments," said Roger Stadler, CEO of icotec.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory