Device Dossier
Durasul® Alpha Hooded Inserts - Constrained polyethylene acetabular liner
Device Dossier for Durasul® Alpha Hooded Inserts - Constrained polyethylene acetabular liner (Constrained polyethylene acetabular liner, Class III,…
- GMDN category: Constrained polyethylene acetabular liner
Intended purpose
Durasul Alpha Hooded Inserts are 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
Hooded 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 highly cross linked Ultra High Molecular Weight Polyethylene (Durasul® PE) and is for uncemented use.