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…
- GMDN category: Non-constrained polyethylene acetabular liner
- Sponsor: B Braun
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.