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The FitRite™ Total Hip Arthroplasty System is indicated for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The FitRite™ DDH Femoral Stems, Standard Femoral Stems, and Acetabular Cups are intended for cementless application: the FitRite™ Cemented Femoral Stems are intended for cemented application.

The FitRite™ Total Hip Arthroplasty System is used for primary total hip replacement in skeletally mature individuals. The system consists of uncemented femoral stems, CoCr femoral heads in various sizes and offsets, uncemented acetabular cups and conventional polyethylene liners. Instrumentation necessary for proper implantation is also included. The purpose of this submission is to introduce additional sizing of the cemented stems.

Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. The Excera FitRite™ Total Hip Arthroplasty System is indicated for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The FitRite™ DDH Femoral Stems, Standard Femoral Stems, and Acetabular Cups are intended for cementless application; the FitRite™ Cemented Femoral Stems are intended for cemented application.

The Excera Orthopedics FitMore™ Total Hip Arthroplasty System is intended to be used for primary total hip replacement in skeletally mature individuals. The System's modular design provides a large selection of component sizes. The System includes three stem designs; a double tapered Femoral Stem (uncemented) with the proximal metaphyseal portion CpTi plasma spray coated, a double-tapered Femoral Stem (un-cemented) with the same essential proximal taper inclusive of a distal stem portion to be inserted in the diaphysis, and the Optimum Femoral Stem (Cemented), a collarless, highly polished double-taper cemented Femoral Stem with design features known to provide reliable performance. The System's CoCrMo Femoral Heads interlock with the Femoral Stems via a standard taper attachment, providing accurate placement and secure fixation. There are three different uncemented Acetabular Cup designs allowing for adjunct fixation; two with specifically designed screw hole patterns, and one with protruding "spurs" designed to fixate to the previously prepared acetabular surface. The Ti6Al4V Acetabular Cups are CpTi plasma spray coated on the trabecular surface. The Ti6A14V Acetabular Screws are available in 6 lengths from 15 to 40mm in 5mm increments. The conventional non-cross-linked UHMWE Acetabular Liners are available in various diameters corresponding to the Femoral Heads and Acetabular Cups, and in 10 degree elevated and standard, non-elevated rim configurations.