icotec Begins U.S. Launch of BlackArmor Anterior Cervical Plate

By Julie A. Vetalice

icotec Begins U.S. Launch of BlackArmor Anterior Cervical Plate

icotec commenced U.S. release of the world's reportedly first 100% nonmetallic Anterior Cervical Plate System (ACP), following FDA 510(k) market clearance. The system has been employed in over 1,000 cases in Europe.

The icotec ACP is made of BlackArmor® Carbon/PEEK material, which is nonmetallic and radiolucent. The material helps reduce artifacts in post-op imaging and has mechanical properties that support less stress shielding at the implant site.

Pre-contoured plates adapt to the cervical anatomy in sizes between 21 and 94mm to span between 1 and 4 spinal segments.

Roger Stadler, CEO of icotec, said, "The icotec Anterior Cervical Plate System complements the previously introduced KONG®-C VBR M Vertebral Body Replacement System made of BlackArmor® material and allows, for the first time, the integrity of the cervical spine in patients requiring surgery for advanced stage tumors, be restored completely with 100% nonmetallic implants, which offers potentially significant additional treatment options for tumor patients."

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Product Launch, Regulatory