Bone-screw internal spinal fixation system, non-sterile

Intended purpose

Intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) Spondylolisthesis, Trauma (i.e. fracture of dislocation), Spinal stenosis, Curvatures (i.e., scoliosis, kyphosis, and/or lordosis), Tumor, Pseudarthrosis, Failed previous fusion When used for posterior, non-cervical, pedicle screw fixation in paediatric patients, the implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, intended to treat paediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Paediatric pedicle screw fixation is limited to a posterior approach.