Pilot Study to Assess Safety/Preliminary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery

Inclusion Criteria: * Documented diagnosis of DDD requiring single level fusion (L2-S1) with up to Grade I Spondylolisthesis * Have a preoperative screening qualifying VAS and ODI scores * Be a skeletally mature male or a non-pregnant, non-lactating female, age 18 -70 inclusive * Have not been sufficiently responsive to at least 6 months of non-operative treatment prior to study enrollment Exclusion Criteria: * Are female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following the surgery * A history of previous surgery in the lumbar spine with or without attempted fusion * Grade II or greater spondylolisthesis * More than 0 degrees of kyphosis at the operated disc space * Evidence of scoliosis in the lumbar region of more than 10 degrees * Collapsed disc space with bridging osteophytes * A systemic or local infection at the site of surgery * An acute fracture of the spine at the time of enrollment in the study * An active history of systemic malignancy * A medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study * A known hypersensitivity to any of the components of the product or a known titanium allergy or a known allergy to polyetheretherketone (PEEK) * A history of any autoimmune disease, such as, systemic lupus erythematosus, Addison's disease, Crohn's disease, or rheumatoid arthritis * A history of any…