ALTSTÄTTEN, Switzerland and BOSTON — November 13, 2025 — Leads & Copy — Icotec, a pioneer in implantable devices made from BlackArmor® Engineered Carbon/PEEK, announced today that the U.S. Food and Drug Administration (FDA) has cleared the CMORE® CT System for use in the cervicothoracic spine.
The CMORE® (CT) System is an enhanced set of instruments and implants designed for posterior stabilization of the upper spine. These spinal implants, crafted with nonmetallic and radiolucent BlackArmor® technology, now facilitate a full spectrum of treatment modalities in adjuvant tumor therapy and enhance postoperative imaging diagnostics in the cervicothoracic spine.
The system consists of a comprehensive portfolio of polyaxial screws, straight and precontoured rods, and axial and parallel connectors. The CMORE® CT System provides the versatility needed to accommodate variations in patients’ anatomy and pathology.
BlackArmor® Engineered Carbon/PEEK is a composite material combining continuous, high-strength carbon fibers and PEEK, manufactured using a process developed by icotec. The resulting implant component features an interwoven 3D fiber architecture and is radiolucent in all diagnostic imaging modes (MRI, CT, and X-ray).
Christoph Eigenmann, CEO of icotec Medical, U.S., stated that the FDA clearance of the CMORE® CT System marks a milestone in the company’s commitment to advancing care for patients with spinal tumors, infections, and complex pathologies. He added that by expanding their BlackArmor® technology to the posterior cervical spine, they are giving surgeons and radiation oncologists a new level of visibility and confidence in their postoperative and oncological decision-making.
icotec is preparing for the upcoming commercial launch of the CMORE® CT System in the United States. This system will expand icotec’s portfolio of BlackArmor® Engineered Carbon/PEEK implants, which are designed for artifact-free imaging and seamless integration across the spine.
icotec is a company focused on the treatment of spinal tumors and other indications with a new generation of high-tech implants. With its BlackArmor® Engineered Carbon/PEEK implants, icotec combines cutting-edge technologies and industry expertise to deliver innovative and reliable solutions for spine surgeons and their patients and is dedicated to advancing the field of spinal implantation.
With a track record of clinical success and a commitment to continuous innovation, icotec is poised to shape the future of spinal surgery. The comprehensive product portfolio has received FDA and CE clearance and is supported by numerous Key Opinion Leaders and spine surgery centers worldwide.
Contact:
Craig Wencis
Senior Vice President of Marketing and Education
craig.wencis@icotec-medical.com
Source: icotec
