icotec, known for developing implantable devices using its BlackArmor® Engineered Carbon/PEEK material, has received clearance from the U.S. Food and Drug Administration for the CMORE® CT System.
This approval allows the system to be used in the posterior cervicothoracic area of the spine.
The CMORE® CT System includes a full range of tools and implants designed to stabilise the upper spine.
It supports different treatment needs, particularly for patients with spinal tumours, infections, or other complex conditions.
The portfolio contains polyaxial screws, straight and shaped rods, and various connectors, enabling surgeons to adapt to different anatomical and clinical requirements.
BlackArmor® Engineered Carbon/PEEK combines strong continuous carbon fibres with PEEK, using a manufacturing method developed by icotec.
The result is a durable implant with a three-dimensional fibre structure that remains radiolucent during MRI, CT, and X-ray imaging. This allows clearer postoperative scans and supports accurate treatment planning.
With this latest approval, icotec has extended the use of its non-metallic technology throughout the upper spine.
The company is preparing for the commercial launch of the CMORE® CT System in the United States, further broadening its product line focused on improved imaging and spinal care.