Device Dossier

Sulene® PE Alpha Inserts - Non-constrained polyethylene acetabular liner

Device Dossier for Sulene® PE Alpha Inserts - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class III,…

Intended purpose

• 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

An 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. Manufactured from Ultra-High Molecular Weight (Sulene®-PE) ISO 5834-2 and are for uncemented use.

TGA Public Summary