Device Dossier

AS EnduRo Tibial Component Offset Cemented - Rotating hinged total knee prosthesis

Device Dossier for AS EnduRo Tibial Component Offset Cemented - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III,…

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

The AS Enduro tibia is a cemented rotating hinge component made from CoCrMo with a multilayer CrN-CrCN-ZrN coating. Compatible with AS Meniscal Component and houses the rotation axis which prevents dislocation by a conical junction and securing nut. Allowance for tibial stem and spacers. A mechanism is integrated in the tibial plateau to provide +/- 6mm medial/lateral off-set of tibial stems. Provides +/- 12° of rotation on the vertical axis in medial/lateral directions.

TGA Public Summary