INDICATIONS
The INFINITY™ OCT 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 (C1 to C7), and the thoracic spine from T1-T3:
- Traumatic spinal fractures and/or traumatic dislocations.
- Instability or deformity.
- Failed previous fusions (e.g. pseudarthrosis).
- 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 INFINITY™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the INFINITY™ OCT System may be connected to the CD HORIZON™ Spinal System and VERTEX™ Reconstruction System rods with the INFINITY™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY™ OCT System to the CD HORIZON™ Spinal System.
Refer to the CD HORIZON™ Spinal System package insert and VERTEX™ Reconstruction System package insert for a list of the indications of use. Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
RISKS
Along with the benefits of this technology, there are also potential risks. Risks associated with the INFINITY™ OCT System include, but are not limited to:
- Disassembly, bending, and/or breakage of any or all of the components
- Pressure on the skin from the component parts which could cause skin penetration, irritation, and/or pain, tissue or nerve damage, and/or scar formation