Bone-screw internal spinal fixation system, non-sterile

Intended purpose

The systems are intended for immobilization and stabilization of the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following: • Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). • Spondylolisthesis • Fracture • Spinal deformities such as scoliosis, kyphosis, lordosis • Tumor • Revision of failed fusion attempts • Pseudarthrosis • Spinal stenosis