Fixation device, internal, spine, construct

Intended purpose

For immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumour, pseudarthrosis, and/or 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 adolescent idiopathic scoliosis. Intended to be used with auto graft and/or allograft. Paediatric pedicle screw fixation is limited to a posterior approach.