Device Dossier

M.E. Müller® Sulene® Low Profile Cup - Polyethylene acetabulum prosthesis

Device Dossier for M.E. Müller® Sulene® Low Profile Cup - Polyethylene acetabulum prosthesis (Polyethylene acetabulum prosthesis, Class III, sponsor…

Intended purpose

The MEM Sulene Low Profile Cup is indicated for patients with 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

The MEM Low Profile Cup is an acetabular cup component designed to be used in conjunction with a femoral head component for replacement of the acetabulum in total hip arthroplasty. Manufactured from Sulene® PE, a high-quality conventional polyethylene. The device contains a radiological mark made from CP Titanium (Protasul®-Ti). Intended for cemented use only.

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