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G.K.S. PRIME FLEX CR is indicated for use in patients with severely painful and disabled joints due to: - Osteoarthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis . - Failed osteotomies - Avascular necrosis of femoral condyle . - Post traumatic loss of joint configuration - Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability - Primary implantation failure if there is sufficient bone . The device is intended for cemented use only.

The GKS Prime Flex CR Total Knee System is a tricompartmental fixed bearing total knee prosthesis comprised of femoral, patellar, and tibial components with ultra-high molecular weight polyethylene articular inserts. The femoral components are offered in left and right versions in eight sizes each. The tibial baseplate components are offered in seven sizes offered in two styles: Universal which will work with either left or right knees and Anatomic which provides components anatomically shaped for left and right knees. The keel has a cylindrical body with two stabilizing wings and allows for future use of extension stems. The tibial inserts fit into the tibial baseplates by a snap-in mechanism. The cruciate retaining tibial inserts are offered in seven sizes, each size in four thicknesses from 10 mm to 18 mm. These tibial inserts work with the universal design or either the left or right anatomic version. The patella is offered in four sizes from 32 to 38 mm. The devices are for cemented use only. The bone opposing surfaces are not coated but have their surfaces roughened by sand blasting. The tibial baseplates come with threaded plugs for bone screw holes as no bone screws are available with this system. A distal plug for a future extension stem is also provided. The GKS Prime Flex CR Total Knee System femoral components are made of Cobalt Chromium Molybdenum (CoCrMo) according to ISO 5832-4. Tibial baseplate components, threaded plugs for screw holes, and distal plug are made of titanium alloy (Ti6-Al4-V) according to ISO 5832-3. Tibial inserts and patellar components are made of standard ultra-high molecular weight polyethylene (UHMWPE) according to ISO 5834-1/2.