Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

The iUni G2 Unicompartmental Resurfacing Device (iUni) is an FDA cleared and CE Marked
implant designed for patients with damage isolated to either the medial or lateral
tibiofemoral compartment of the knee. The study subjects will be followed for 10 years post
implant. The study objective is to evaluate the safety and performance of the ConforMIS iUni®
Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis.
The iUni is a patient-specific unicompartmental resurfacing device designed from the
patient's unique anatomy using proprietary software which interprets data from the patient's
CT scan. The patient matched implant design is then coupled with unique patient-matched
disposable instrumentation designed using the same CT data and software. The follow-up visit
schedule will include visits at 6 weeks, 6 months (optional), 1 year, 2 years, 5 years and 10
years post implant.The remaining follow-up data collected at years 3, 4, 6, 7, 8, and 9 may
be collected via phone call/email and does not require a subject visit to the site.The study
sites will be located in the United States.

Inclusion Criteria:

1. Clinical condition included in the approved Indications For Use

2. Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment

3. Willingness to participate in the clinical study, to give informed consent and to
attend all follow-up visits

4. > 18 years of age

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