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.
The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System. The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) devices and all-polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.