icotec Gains Clearances for KONG VBR Spinal Systems

By Julie A. Vetalice

icotec Gains Clearances for KONG VBR Spinal Systems

icotec's KONG®-TL and the KONG®-C vertebral body replacements received FDA 510(k) clearance in the U.S. and CE Mark approval in Europe.

The devices are made from radiolucent, nonmetallic BlackArmor® material with a 360° osseoconductive Ti-iT® pure titanium coating.

The 360° Ti-iT pure titanium coating, featuring an optimized osseoconductive structure,  is designed to support rapid engraftment of bone onto the implant. BlackArmor Carbon/PEEK implant material enables artefact-free imaging and aids in planning, application and follow-up care of radiotherapy for patients with tumors.

"With the imminent market launch of the KONG-TL/C vertebral body replacement systems in Europe and the U.S., we have made significant strides toward achieving this target [of establishing a complete product portfolio that provides patients with improved therapy options]," said Roger Stadler, CEO.

Product Labels: Spinal Fusion