Bone-screw internal spinal fixation system, non-sterile

Intended purpose

When used as a pedicle screw fixation system in skeletally mature patients, the device is indicated to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis and/or 7. Spinal tumor When used for posterior, non-cervical screw fixation in pediatric patients, the device is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis; progressive spinal deformities including congenital scoliosis, juvenile idiopathic scoliosis, and neuromuscular scoliosis; and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.