Durasul® Alpha Inserts - Non-constrained polyethylene acetabular liner

Intended purpose

The Durasul Alpha Insert is an insert component of the Allofit®/Allofit®-S Alloclassic® Acetabular Cup System used in conjunction with an acetabular cup component and a femoral head for replacement of the acetabulum in total hip arthroplasty. The device is indicated for noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis; failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty; total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.

Functional description

A Insert component of the The Allofit®/Allofit®-S Alloclassic® Cup System for articulation with the appropriate cup (shell and Insert) and femoral head component in the treatment of degenerative disease. It is made from Ultra High Molecular Weight Polyethylene (Durasul® PE) ISO 5843-2 and is for uncemented use.