Device Dossier

Allofit® IT Alloclassic® Acetabular Shell - Metallic acetabulum prosthesis

Device Dossier for Allofit® IT Alloclassic® Acetabular Shell - Metallic acetabulum prosthesis (Metallic acetabulum prosthesis, Class III, sponsor Zimmer…

Intended purpose

Indicated for noninflammatory degenerative joint disease (NIDJD) and inflammatory joint disease (IJD), failed previous surgery where pain, deformity, or dysfunction persists, revision of previously failed hip arthroplasty. 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 acetabular cup component used in conjunction with a femoral head component for replacement of the acetabulum in total hip arthroplasty. It has a flattened, hemispherical shell with tooth-like circumferential macrotexture for fixation. It is manufactured from Protasul®-Ti and indicated for uncemented use.

TGA Public Summary