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Indications: Indications for Total Knee Replacement: - 1. Rheumatoid arthritis, - 2. Correction of functional deformity. - 3. Osteoarthritis. 4. Degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 5. Failed osteotomies, unicompartmental replacement, or total knee replacement. The femoral component and tibial tray are for cemented use (biological fixation). The patellar component and metaphyseal stem (K080199) are for cemented use only. Indications for Posterior Stabilized Knee Replacement: Posterior stabilized knee systems with a deep articular surface are designed for use in patients in primary and revision surgery, where the anterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Total Knee indications still apply. Indications for Constrained Knee Replacement: Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/ or lateral collateral ligament) are absent or incompetent. Total Knee indications still apply.

The Agility Symmetric™ Total Knee System is intended for the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem previously cleared in K080199) and a potellar component (also cleared in K080199). The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/ molybdenum (CoCrMo). The femoral component is available in five sizes (3-7) and will have two condylar pegs to aid in rotational stability. It is mesh coated with ASTM F67 titanium. The TIBIAL TRAY is a symmetric designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti6Al4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside providing rotational stabilization and increased tray strew holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting an ultra-high polyethylene (UHMWPE) tibial insert to be snapped into place. The tibial tray has 5 sizes (3-7) and is mesh coated with ASTM F67 titanium. Mating geometries for the previously cleared (K080199) TIBIAL INSERT, METAPHYSEAL STEM, REVISION STEM, and PATELLAR COMPONENT have not changed from the predicate devices.