Device Dossier

AS EnduRo Femoral Component Cemented - Rotating hinged total knee prosthesis

Device Dossier for AS EnduRo Femoral Component 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

Cemented, constrained femoral prosthesis for the Enduro Rotating Hinge System.Made from CoCrMo with a multilayer CrN-CrCN-ZrN coating.Includes pre-assembled hinge mechanism consisting of flexion axis, bearing elements and hinge ring, packaged together with safety nut and cement protection mask. Allowance for femoral augments & stems.Conical junction with securing nut to prevent dislocation with up to 140° of flexion. Provides +/- 12° of rotation on the vertical axis in medial/lateral directions.

TGA Public Summary