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)