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When used as a pedicle screw fixation system, the Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis) The Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Spinal System is also intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Spinal stenosis 3. Spondylolisthesis 4. Spinal deformities 5. Fracture 6. Pseudoarthrosis 7. Tumor resection and/or 8. Failed previous fusion The Teslake Spinal System Navigation Instrumentation is intended to be used during the preparation and placement of Teslake Spinal System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Spinal System consists of a variety of polyaxial screws, fixed angle screws, rods, hooks, locking nuts, and transverse connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of the current submission is to add additional implants and navigated instruments to the Teslake Spinal System.