Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

Exclusion Criteria

• •1. Simultaneous bilateral procedure required
• •2. BMI \> 35
• •3. Treatment for cancer within the past 5 years, with the exception of skin cancer
• •4. Poorly controlled diabetes
• •5. Neuromuscular conditions which prevent patient from participating in study activities
• •6. Active local or systemic infection
• •7. Immunocompromised
• •8. Fibromyalgia or other general body pain related condition
• •9. Advanced tricompartmental osteoarthritis
• •10. Symptomatic patellofemoral disease
• •11. Rheumatoid arthritis or other forms of inflammatory joint disease
• •12. Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified
• •13. Advanced loss of osteochondral structure on the affected femoral condyle
• •14. Compromised ACL, PCL or collateral ligament
• •15. Severe (\>15º) fixed valgus or varus deformity
• •16. Extension deficit \> 15 º
• •17. Prior history of failed implant surgery of the joint to be treated
• •18. Unwilling or unable to comply with study requirements
• •19. Participation in another clinical study which would confound results