Condition of Approval Study

Exclusion Criteria

• •1. has a baseline score less than or equal to 2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire
• •2. cannot sit for 50 minutes
• •3. cannot walk more than 50 feet
• •4. has unremitting pain in any spinal position
• •5. has axial back pain only without leg/buttock/groin pain
• •6. has a fixed motor deficit
• •7. has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction
• •8. has severe symptomatic lumbar spinal stenosis at more than two levels
• •9. has significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1 to 4)
• •10. has an ankylosed segment at the affected level(s);
• •11. has significant scoliosis (Cobb angle is greater than 25 degrees)
• •12. has an acute fracture of the spinous process or pars interarticularis
• •13. has sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and /or hips
• •14. has severe osteoporosis of the spine or hip, defined as bone mineral density (BMD) in the spine or hip more than 2.5 SD below the mean of adult normals in the presence of one or more fragility fractures
• •15. has Paget's disease at the involved segment(s) or metastasis to the vertebrae
• •16. has had any surgery of the lumbar spine
• •17. has significant peripheral neuropathy demonstrated by nerve conduction velocity tests
• •18. has acute denervation secondary to radiculopathy, as shown by EMG
• •19. has significant peripheral vascular disease characterized by diminished dorsalis pedus or tibial pulses
• •20. has extreme obesity as defined by a Body Mass Index (BMI) greater than 40 kg/m2
• •21. has an active systemic infection or infection localized to the site of implantation
• •22. has an active systemic disease such as AIDS, HIV, hepatitis, etc.
• •23. has a medical condition that may interfere with postoperative management and follow-up, or may result in patient death prior to study completion (e.g., Alzheimer's disease, unstable cardiac disease, active malignancy)
• •24. has a recent history of narcotic abuse (i.e., within last 3 years)
• •25. has a known allergy to titanium,titanium alloy, or polyetheretherketone
• •26. is immunologically suppressed, or has received or is receiving steroids at any dose daily for more than one month within the last 12 months
• •27. is currently involved in a study of another investigational product that may affect the outcome of this study
• •28. is pregnant or planning to become pregnant during the study period
• •29. cannot undergo MRI or tolerate closed MRI scanning.