Fixation device, internal, spine, construct

Intended purpose

The TRANSITION Stabilization System and ZYFLEX Stabilization System are intended to provide spinal alignment and dynamic stabilization in skeletally mature patients in up to five contiguous levels of the thoracic, lumbar and sacral spine. The systems are intended to be used for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, degenerative spondylolisthesis with objective evidence of neurologic impairment, spondylosis, spinal stenosis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.