Bone-screw internal spinal fixation system, non-sterile

Intended purpose

Intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined 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. When used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, the System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical pedicle screw fixation in paediatric patients. The System for paediatric use is intended to be used with autograft and/or allograft. Paediatric pedicle screw fixation is limited to a posterior approach.