COSY Cervicothoracic Occipital Rod-Screw System - Bone-screw internal spinal fixation system, non-sterile

Intended purpose

The COSY Cervicothoracic Occipital Rod-Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C 1-C7), and the thoracic spine from Tl -T3: traumatic spinal fractures and/or traumatic dislocations; instabilities or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The COSY cervicothoracic occipital rod-screw system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of limited duration to permit achievement of fusion. In order to achieve additional levels of fixation, the COSY Cervicothoracic Occipital Rod-Screw System may be connected to the components of the DIPLOMAT System or MONOPOLY System using the rod-to-rod connectors or transition rods.