The Spinal Fixation System is intended for non-cervical use in the spine.  The Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

1. Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
2. Who are receiving fusion using autogenous bone graft only;
3. Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
4. Who are having the device removed after the development of a solid fusion mass.

Applicability:

The Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended 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 thoracic, lumbar and sacral spine:

1. Degenerative spondylolistheses with objective evidence of neurologic impairment;
2. Fracture;
3. Dislocation;
4. Scoliosis;
5. Kyphosis;
6. Spinal tumor; and
7. Failed previous fusion (pseudoarthrosis).

Applicability:

The Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

1. Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
2. Spondylolisthesis;
3. Spinal stenosis;
4. Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
5. Tumor;
6. Pseudoarthrosis;
7. Failed previous fusion; and
8. Trauma (i.e., fracture or dislocation).

Applicability:

The Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:

1. Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
2. Spondylolistheses;
3. Spinal stenosis;
4. Spinal deformities (i.e., scoliosis, kyphosis, lordosis);
5. Tumor;
6. Pseudoarthrosis;
7. Failed previous fusion; and
8. Trauma (i.e., fracture or dislocation).

Applicability: