icotec announced that U.S. Food and Drug Administration (FDA) has cleared its CMORE CT system for use in the cervicothoracic spine.

CMORE is an enhanced set of instruments and implants for posterior stabilization of the upper spine. With its FDA nod, the company’s spinal implants made of nonmetallic and radiolucent BlackArmor technology now have a full spectrum of treatment modalities in adjuvant tumor therapy and enable post-op imaging diagnostics in the cervicothoracic spine.

The system consists of a portfolio of polyaxial screws, straight and precontoured rods, and axial  and parallel connectors. The company said CMORE offers the versatility needed to accommodate variations in anatomy and pathology.

BlackArmor engineered carbon/PEEK is a combination composite material with continuous, high strength carbon fibers and PEEK, manufactured in a proprietary process. The result is an implant component with an interwoven 3D fiber architecture that’s radiolucent in MRI, CT, and X-ray.

“The FDA clearance of the CMORE CT System marks another milestone in our commitment to advancing care for patients with spinal tumors, infections, and complex pathologies,” said Christoph Eigenmann, CEO of icotec Medical, U.S. “By expanding our BlackArmor technology to the posterior cervical spine, we’re giving surgeons and radiation oncologists a new level of visibility and confidence in their postoperative and oncological decision-making.”

Earlier this year, the company’s BlackArmor implants were FDA cleared to treat de novo spinal infections. icotec also inked an exclusive distribution agreement with Osteotec in May to distribute its non-metallic spinal implants for spine tumor therapy.