Bone-screw internal spinal fixation system, sterile

Intended purpose

When used with bone augmentation material, the augmentable screws are intended for posterior, non-cervical pedicle fixation as an adjunct to fusion in patients with diminished bone quality such as osteoporosis for the following indications: degenerative disc disease (define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion