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1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis , and avascular necrosis. 2. Rheumatoid Arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications

The purpose of this Special 510(k) is to expand the Provident Hip System with a line extension to the existing Provident Hip Stems. The new stems are to be marketed as the Provident II Hip Stems and feature a shortened stem.

The GENFlex2 Total Knee System is intended for: · Total knee replacement due to osteoardis, theumatoid arthritis, and/or post-traumatic degenerative problems. · Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The device is intended for cemented use only.

The purpose of this Special 510(k) is to add the Ultra-Congruent CR Tibial Insert to the GENFlex2 Total Knee System. The Ultra-Congruent CR Tibial Insert is a component within a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The articulating geometry of the Ultra-Congruent CR Tibial Insert provides for increased stability relative to the predicate CR insert. The inserts are manufactured from EXp Vitamin E Polyethylene and Conventional Polyethylene.

The GENFlex2 Total Knee System is intended for: ● Total knee replacement due to osteoarthritis, osteonecrosis rheumatoid arthritis, and/or post-traumatic degenerative problems. ● Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The device is intended for cemented use only.

The GENflex2 System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to modify the geometries of the Posterior Stabilized and the Cruciate Retaining tibial insert and femoral component. These components are manufactured from EXp Vitamin E Polyethylene, Conventional Polyethylene and Cobalt Chrome Alloy. Each component is available in a range of sizes that complement each other.