Device Dossier
EnduRo Meniscal Component - Rotating hinged total knee prosthesis
Device Dossier for EnduRo Meniscal Component - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor B Braun).…
- 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
Meniscal component for EnduRo rotating hinge, constrained knee prosthesis, made from Polyethylene UHMWPE, ISODUR®‐F, CoCrMo with x-ray markers made of Ti6Al4V. Includes bearing sleeve, rotation axis and locking ring. 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 and 140° flexion angle.