• Subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:

‣ Instability as defined by \>3mm translation or \>5 degrees angulation

⁃ Osteophyte formation of facet joints or vertebral endplates

⁃ Decreased disc height, on average by \>2mm, but dependent upon the spinal level

⁃ Herniated nucleus pulposus

⁃ Facet joint degeneration/changes