Device Dossier

EnduRo Femoral Component Cemented - Rotating hinged total knee prosthesis

Device Dossier for EnduRo Femoral Component Cemented - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor B…

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 femoral component for EnduRo rotating hinge, constrained knee prosthesis, made from ISODUR®‐C, CoCrMo with at least 140° flexion angle. Security against dislocation is provided by joined cone with additional securing nut. 12° rotation on the vertical axis is possible in both medial and lateral directions.

TGA Public Summary