Post-Market Study of the 3DKnee™ System

Total knee replacement surgery is widely accepted as effective treatment for degenerative
joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and
return of mobility are the primary goals that can be accomplished by this surgery. The
purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total
knee replacement surgery. The study will take place at multiple sites across the United
States and be managed by the Encore Medical Clinical Affairs Department. The study will
include only patients who meet the indications for use criteria for the 3DKnee™ System and
who are candidates for primary knee arthroplasty.

Inclusion Criteria:

- This must be a primary knee replacement on this knee.

- Patient is over 18 years of age or older

- Have knee joint disease related to one or more of the following

- degenerative joint disease, including osteoarthritis or traumatic arthritis

- Avascular necrosis of the femoral condyles

- Post-traumatic loss of joint configuration, particularly when there is
patellofemoral erosion, dysfunction or prior patellectomy

- Moderate valgus, varus, or flexion deformities

- Rheumatoid arthritis

- Patient is likely to be available for evaluation for the duration of the study

- Able and willing to sign the informed consent and follow study procedures

- Patient is not pregnant

Exclusion Criteria:

- Is younger than 18 years of age

- If there has been a total knee replacement on this knee in the past (no revisions
allowed in study)

- Infection, or history of infection, acute or chronic, local or systemic

- Alcoholism or other addictions

- Muscular, neurological or vascular deficiencies which compromise the affected
extremity

- Obesity

- Insufficient bone quality

- Loss of ligamentous structures

- High levels of physical activity

- Materials sensitivity

- Prisoner

- Mental conditions that may interfere with the patient's ability to give an informed
consent or willingness to fulfill the study requirements

- Patient is pregnant