Device Dossier

Plasmafit PE Cup Insert Symmetrical UHMWPE - Non-constrained polyethylene acetabular liner

Device Dossier for Plasmafit PE Cup Insert Symmetrical UHMWPE - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular…

Intended purpose

The implant is used as a component part of a human hip endoprosthesis to combine with Aesculap hip endoprosthesis components for implantation without bone cement. Use for acute disorders of the hip that cannot be treated by other therapies: - Degenerative osteoarthritis - Rheumatic arthritis - Fractures of the joint - Femoral head necrosis

Functional description

The 32mm symmetrical inserts are made of UHMWPE highly cross-linked polyethylene. The fixation of the liners is realized by a conical locking mechanism. The conical fixation surface area also forms a seal against the migration of polyethylene particles from the articulating joint. In the primary load area the liners have a minimum thickness of 5.5 mm. The fixation has a high stability against tilting and rotation forces in vivo.

TGA Public Summary