Fixation system, internal,fracture, non-biodegradable

Intended purpose

The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors. The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions or placement in the cervical spine (C1-C7) in treating cervical conditions. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine. The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.5mm to 6.5mm, including the PROTEX® or REVERE® or BEACON™ System, using corresponding parallel connectors