MAVERICK™ Total Disc Replacement- Pivotal Study

Inclusion Criteria: * Has DDD as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history * Has 1 or more of the following documented by CT, MRI, or plain x-rays: modic changes, high intensity zones in the annulus, loss of disc height, decreased hydration of the disc * Has documented annular pathology * Has single-level symptomatic degenerative involvement from L4-S1 requiring surgical treatment * Has intact facet joints at the involved vertebral levels documented by CT and/or MRI * Has preop Oswestry score≥30 * Has preop back pain score ≥20 * Age 18 to 70 yrs who are skeletally, mature, inclusive * Has not responded to non-operative treatment for 6 mos * If child-bearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant for 1 yr after surgery * Is willing and able to comply with the study plan and sign the Patient Informed Consent Form Exclusion Criteria: * Has primary diagnosis of a spinal disorder other than DDD at involved level * Had previous posterior lumbar spinal fusion surgical procedure at involved level * Had prior posterior lumbar surgery resulting in significant muscle/ligament morbidity, not including facet saving techniques * Had previous anterior lumbar spinal surgery at involved level * Requires spinal fusion and/or arthroplasty at more than 1 lumbar level * Has severe pathology of facet joints of involved vertebral bodies * Has any posterior element insufficiency * Has spondylolisthesis * Has spinal canal stenosis * Has rotatory scoliosis at involved level * Level treated has fractures secondary to trauma * Has any of the following that may be associated with a diagnosis of osteoporosis (if Yes, a DEXA Scan is required): Postmenopausal Non-Black female over 60 yrs of age and weighs less than 140 pounds; Postmenopausal female that has sustained a non-traumatic hip, spine or wrist fracture; Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If level of BMD is -3.5 or lower or -2.5 or lower with vertebral crush fracture, the patient is excluded * Has fever (temp \> 101°F oral) at time of surgery * Has a condition that requires postop medications that interfere with fusion, such as steroids or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative, non-steroidal anti-inflammatory drugs. Does not include low dose aspirin for prophylactic anticoagulation * Has overt or active bacterial infection, either local or systemic and/or potential for bacteremia * Has presence or prior history of malignancy (except for basal cell carcinoma of skin) * Has documented metal allergy, titanium alloy intolerance or cobalt-chrome-molybdenum alloy * Is mentally incompetent. If questionable, obtain psych consult * Has a Waddell Signs of Inorganic Behavior score of 3 or greater * Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease * Is prisoner * Is pregnant * Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse * Has received drugs that may interfere with bone metabolism within 2 weeks prior to the surgery date, excluding routine perioperative, non-steroidal anti-inflammatory drugs * Has history of autoimmune disease * Has history of exposure to injectable collagen implants * Has history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen * Has received treatment with an investigational therapy within 30 days prior to implantation surgery or treatment is planned during 24 months following the implantation surgery * Has received any previous exposure to any/all BMP's of either human or animal extraction * Has history of allergy to bovine products or a history of anaphylaxis * Has history of any endocrine or metabolic disorder known to affect osteogenesis * Has any disease that would preclude accurate clinical evaluation