Inclusion Criteria are identical to the indications for use stated in the FDA cleared labeling for the device in 510(k) K093293. These indications are stated below:
A. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, where one or more compartments are involved;
B. Correction of varus, valgus or posttraumatic deformity;
C. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of a previous total joint replacement procedure.
Patient selection factors to be considered include:
A. Need to obtain pain relief and improve function,
B. Ability and willingness of the patient to follow instructions, including control of weight and activity level,
C. A good nutritional state of the patient, and
D. The patient must have reached full skeletal maturity.