iFuse Implant System® Minimally Invasive Arthrodesis

Exclusion Criteria

• •1. Severe lower back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture
• •2. Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
• •3. History of recent (\<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring.
• •4. Spine surgery during the past 12 months.
• •5. Previously diagnosed or suspected osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture)
• •6. Documented osteomalacia or other metabolic bone disease
• •7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
• •8. Known allergy to titanium or titanium alloys
• •9. Use of medications known to have detrimental effects on bone quality and soft-tissue healing
• •10. Prominent neurologic condition that would interfere with physical therapy
• •11. Current systemic infection or local infection at the SI joint
• •12. Currently pregnant or planning pregnancy in the next year
• •13. Known or suspected drug or alcohol abuse
• •14. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
• •15. Patient is participating in an investigational study or has been involved in an investigational study within 3 months of surgery