Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)

Inclusion Criteria: * Subjects with back and/or leg pain electing to receive Transforaminal Lumbar Interbody Fusion (TLIF)/ Posterior Lumbar Interbody Fusion (PLIF) procedure and posterior transpedicular stabilization with or without decompression at any level * Unresponsive to conservative treatment for at least 6 months * Radiographic confirmation of primary diagnosis Exclusion Criteria: * More than 2 levels requiring lumbar interbody fusion * Spondylolisthesis greater than Grade I * Prior failed fusion surgery at any lumbar level(s) * Local or systemic infection past or present * Active systemic disease * Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing * BMI greater than 40 * Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified * Use of post operative Spinal Cord Stimulator (SCS) * Any condition requiring postoperative medications that inhibit fusion, such as chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs * Known or suspected history of alcohol and/or drug abuse * Involved in pending litigation or worker's compensation related to the spine * Pregnant or plans to become pregnant during the course of the study * Insulin-dependent diabetes mellitus * Known sensitivity to device materials * Life expectancy less than duration of study * Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires * Undergoing chemotherapy or radiation treatment * Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)