Post Market Study of the 3DKnee™ With E-plus Insert

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. Currently
available prosthetic designs accomplish these goals and the surgery has been defined as one
of the most successful operations available to improve the quality of life for patients with
DJD. This study will evaluate subjects who are candidates for a total knee replacement and
meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial
inserts (VE).

Inclusion Criteria:

- Subject must be a candidate for a total primary knee replacement.

- Subject must have knee joint disease related to degenerative joint disease, including
osteoarthritis or traumatic arthritis

- Subject has a BMI ≤ 40.00 kg/m2

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

- Subject is able and willing to sign the informed consent and follow study procedures

- Subject is not pregnant

- Subject must be between age 40 and age 75 at the time of consent

Exclusion Criteria:

- Subject has had a prior total or uni-knee replacement on this knee in the past (no
revisions allowed in study)

- Subject has 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 or rheumatoid arthritis

- Subject has an active cancer or is a survivor for <5 years except for squamous cell or
basal cell skin cancer

- Subject has a chronic disease(s) where, in the opinion of the investigator, the
disease will interfere with the patient's ability to follow the protocol

- Subject is currently a documented substance abuser (alcohol or other addictions)

- Subject has an infection, or history of infection (within the last 3 months), acute or
chronic, local or systemic

- Subject has a history of muscular, neurological or vascular deficiencies which
compromise the affected extremity

- Subject has a BMI > 40.00 kg/m2

- Subject has loss of ligamentous structures

- Subject has high levels of physical activity and is unwilling to modify levels of
physical activity commensurate with recommendations

- Subject has a mental condition that may interfere with the subject's ability to give
an informed consent or willingness to fulfill the study requirements (i.e., severe
mental retardation such that the Subject cannot understand the informed consent
process, global dementia, prior strokes that interfere with the Subject's cognitive
abilities, senile dementia, and Alzheimer's Disease)

- Subject is a prisoner

- Subject is pregnant

- Subject has known materials sensitivity (to metals)

- Subject is younger than 40 years (<40) or older than 75 years (>75) at the time of
consent