Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease

Inclusion Criteria: * Single level, degenerative disc disease at L3 to S1, inclusive. * Minimum of 6 months of unsuccessful conservative treatment. * Subject is a surgical candidate for an anterior approach to the lumbar spine (\<3 abdominal surgeries). * Back pain at the operative level only (by discogram, if necessary). * Leg pain and/or back pain due to disc space settling, with or without radicular symptoms related to foraminal narrowing. * Subject must understand and sign the written Informed Consent. Exclusion Criteria: * Prior fusion at any lumbar level. * Clinical evidence of adjacent lumbar segment disease. * Previous trauma to the L3, L4, L5, or S1 levels (in compression or burst). * Non-contained or extruded herniated nucleus pulposus. * Congenital stenosis or central/lateral stenosis (mid-sagittal stenosis of \<8mm by CT or MR) secondary to acquired degenerative disease requiring treatment that destabilizes the spine (requiring fusion), or for subjects in whom increased motion may increase symptoms. * Retro- or spondylolisthesis of ≥ 2.5 mm which is either fixed or present on flexion/extension films, and slippage of vertebral body where the listhesis is due to disc space settling in the absence of degenerative facets or a pars interarticularis defect. * Significant kyphosis (\>11ْ sagittal plane deformity). * History of any invasive malignancy (except non-melanoma skin cancer) unless treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years (in particular, spinal tumors). * Acute or chronic infection (local or systemic). * Instability or facet joint arthrosis, clinically significant. * Arachnoiditis. * Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone. * Radiographic findings of a fused or total collapsed disc. * Subject using medications or drugs known to potentially interfere with bone or soft tissue healing (high-dose of steroids, osteoclast inhibitors, etc.). * Systemic disease affecting the spine, including rheumatoid arthritis, autoimmune disease, AIDS, HIV, or hepatitis. * Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed separately). * Psychosocial disorders (e.g. evidence or drug or alcohol abuse). * Morbid (extreme) obesity (BMI ≥ 40 kg/m2). * Bone growth stimulator use in spine. * Investigational drug or device use within 30 days. * Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan if poor bone quality is suspected (T-score \< -1.0). * If female of childbearing potential, pregnant or interested in becoming pregnant in the next three years. * Type 1 diabetes, and uncontrolled (or poorly controlled) Type 2 diabetes. * Subjects with a history of implant rejection. * Provocative discography with non-concordant pain at the operative level. * Incarcerated subjects. * Myelopathy. * Significant leg pain of a radicular or neurogenic claudication nature. * Involved vertebral endplates dimensionally smaller then 39 mm in the mediallateral and/or 32 mm in the anterior-posterior directions. * Subjects not able to meet follow-up requirements. * Lumbar scoliosis \> 11 degrees. * Any previous or current litigation related to the spine.