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The A3 Total Knee System indications for use is: - Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis) or rheumatoid arthritis. - Correction of functional deformities. - Post-traumatic loss of knee joint configuration and function. - Moderate valgus, varus, or flexion deformity. - . Knee fractures untreatable by other methods. The A3 Total Knee System is indicated for cemented use only.

The subject device and both predicate devices are total knee replacement systems consisting of five components: - 1. Femoral Condyle - 2. Tibial Tray - 3. Tibial Insert - 4. Patellar Component - 5. Locking Mechanism The subject device and both predicates have femoral condyle and tibial tray components manufactured from cast cobalt chromium molybdenum (Co-Cr-Mo) alloy. The femoral components of all devices are available in both left and right configurations. The tibial inserts of the subject device and primary predicate device are manufactured from conventional ultra-high molecular weight polyethylene (UHMWPE), while the reference predicate is manufactured using a combination of UHMWPE and cobalt-chromium (Co-Cr). The range of available sizes of the tibial trays and inserts varies for the subject and predicate devices. The subject device and primary predicate have a patellar component manufactured from UHMWPE, while the material of construct of the patella of the reference predicate is unknown. The subject and both predicate devices have a locking mechanism, although the configurations and method of operation are slightly different. The locking clip for the subject device is manufactured from titanium, the reference predicate locking wire is manufactured from Co-Cr and the material of the primary predicate is unknown. The subject and primary predicate devices have the same maximum degree of flexion (145°), while the maximum flexion of the reference predicate is slightly less (110°). All devices are of a posterior stabilized design and none are cruciate ligament retaining devices. The subject and both predicates are shipped sterile.