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The Optimotion Implants Porous Metal-Backed Patella is intended or cementless applications when resurfacing the surgically prepared patella as part of primary Total Knee Arthroplasty (TKR). The Optimotion Implants Metal-Backed Patella is compatible for use with components of the Optimotion™ Blue Total Knee System components (K191084). General Total Knee Arthroplasty (TKR) Indications: · Painful, disabling joint disease of the knee resulting from; noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic loss of knee joint configurations and function. · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Revision of previous unsuccessful knee replacement or other procedure. · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques. - · Optimotion porous tibial tray and porous CR femoral components are indicated for cemented or cementless use. - · Optimotion cemented CR Femoral and cemented tibial tray components are indicated for cemented use only.

The Optimotion Implants Porous Metal-Backed Patella is an extension of The Optimotion™ Blue Total Knee System (K191084) product line for use in primary Total Knee arthroplasty. The Optimotion Porous Metal-Backed Patella will come in two variations Onset styles. It is a sterile, single use, non-modular porous metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in a symmetric design that is available in multiple sizes. The metal backing features an additive manufactured porous posterior surface and three additive manufactured porous pegs to provide cemented or cementless fixation to bone.

Painful, disabling joint disease of the from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. Post-traumatic loss of knee joint configurations and function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Revision of previous unsuccessful knee replacement or other procedure. Fracture of the distal femur and or proximal tibia that cannot be stabilized by standard fracture-management techniques. Optimotion™ Blue Porous Tibial Baseplate components are indicated for Cementless use. The Optimotion™ Blue Porous CR Femoral components are indicated for Cementless use. The Optimotion™ Blue CEMENTED CR Femoral and CEMENTED Tibial Baseplate components are indicated for cemented use only.

Optimotion™ Blue Total Knee System consists of femoral, tibial tray, tibial insert, and patella resurfacing components, tibial stem extensions and a tibial trays are composed of Ti-6Al-4V alloy, both non-porous (uncoated - cemented) or porous (cemented or cementless). All tibial insert and patella components are composed of UHMWPE with Vitamin E. The tibial stem extensions and plug are composed of Ti-6AI-4V alloy. The femoral components are composed of CoCrMo alloy either uncoated (non-porous - cemented), and coated with porous CoCrMo sintered porous coating. The non-porous cemented tibial tray and femur are only to be used with PMMA bone cement. The porous tibial tray can either be used with cement or cementless. The porous CoCr femur is compatible with both cemented and cementless applications. The Optimotion™ Blue Total Knee System is intended for cemented or uncemented replacement of the tibia, patella and femur articular surfaces of the knee.