Device Dossier
AS EnduRo Meniscal Component - Rotating hinged total knee prosthesis
Device Dossier for AS EnduRo Meniscal Component - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor B…
- GMDN category: Rotating hinged total knee prosthesis
- Sponsor: B Braun
Intended purpose
The implant is used as a component part of a human knee endoprosthesis in combination with Aesculap knee endoprosthetic components. Indications: Severe knee joint conditions that cannot be treated through other therapies: Degenerative osteoarthritis, Rheumatoid arthritis, Posttraumatic arthritis, Symptomatic knee instability, Knee stiffness, Deformation of the knee joint, Knee-joint ankyloses, Revision/Replacement operations. EnduRo is indicated for use in cases of functional deficiency of the collateral ligaments.
Functional description
Constrained meniscal component for EnduRo Rotating Hinge made from UHMWPE and used in combination with AS Enduro Tibial component. Includes meniscal component, rotation axis, rotation bushing & locking ring. Rotation axis and bushing match meniscus component height. Rotation axis and locking ring are made from CoCrMo with a multilayer CrN-CrCN-ZrN coating. Rotation bushing is made from CFR PEEK. Provides +/- 12° of rotation on the vertical axis in medial/lateral directions.