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MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed The MicroPort total hip systems devices are single use only devices.

The subject devices are a variety of hip joint replacement prostheses. The components for these systems include an acetabular shell, acetabular liner, fixation screws, femoral head, femoral stem, modular neck, proximal body, centralizers, bone plugs, and neck sleeves. These components can be utilized in a variety of configurations to assemble the final construct. The femoral and acetabular components are manufactured from a variety of materials which include cobalt-chromium-molybdenum alloy, titanium alloy, unalloyed titanium, alumina ceramic, Alumina Matrix Composite ceramic (Biolox Delta), polymethylmethacrylate (PMMA), and ultra high molecular weight polyethylene (UHMWPE), all of which conform to ASTM or ISO standards, or internal standards. The only changes to the subject hip systems are updates to the labeling of the devices. Specifically, the package inserts and package labels are being updated to include MR Conditional language and symbols. The subjects are identical to the predicates in all aspects except for the labeling updates.