A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

If the patient has previously received a standard total knee replacement in their
contralateral knee, the primary endpoint questionnaire and some secondary endpoint
questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard
total knee for all time points where questionnaires are required by the protocol.

Inclusion Criteria:

- Clinical condition included in the approved Indications For Use for the iTotal® CR

- Osteoarthritis, as confirmed by the investigator's assessment of disease status at
screening visit that warrants a TKR procedure. Disease status is assessed by Clinical
and Radiographic assessment.

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

- > 18 years of age

Exclusion Criteria:

- Simultaneous bilateral procedure required

- BMI > 40

- Active malignancy (defined as a history of any invasive malignancy - except
non-melanoma skin cancer), unless patient has been treated with curative intent and
there have been no clinical signs or symptoms of the malignancy for at least 5 years

- Poorly Controlled diabetes

- Neuromuscular conditions which prevent patient from participating in study activities

- Active local or systemic infection

- Immunocompromised

- Fibromyalgia or other general body pain related condition

- Rheumatoid arthritis or other forms of inflammatory joint disease

- Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in
the area of the joint to be operated to an extent that the procedure is unjustified

- Diagnosed with or receiving treatment for Osteoporosis

- Other physical disability affecting the hips, spine, or contralateral knee.

- Severe instability due to advanced loss of osteochondral structure

- Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)

- Compromised PCL or collateral ligament

- Severe fixed valgus or varus deformity of >15º

- Extensor lag > 15 º

- Fixed flexion contracture ≥ 15 º

- Unwilling or unable to comply with study requirements

- Participation in another clinical study which would confound results

- Allergy to any of the implant materials