Device Dossier

e.motion AS Pro Tibial Plateau Cemented - Uncoated knee tibia prosthesis, metallic

Device Dossier for e.motion AS Pro Tibial Plateau Cemented - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class…

Intended purpose

The implant is used as a component part of a human knee endoprosthesis in combination with e.motion mobile bearing knee endoprosthetic components. Indicated for use as a mobile bearing component that is fixed with cement, e.motion® Pro is indicated for patients requiring primary surgery and indicated for 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

Functional description

The tibial plateau is a Pro cemented mobile bearing implant which is used to resurface the tibia in primary total knee arthroplasty and is made from CoCrMo alloy.It has a safety stop which allows ±30° of rotation.The component has an AS coating in which an additional barrier layer is applied to the conventional CoCrMo component, which prevents the metal ions crossing over from the implant to the patient and thus an allergic reaction,making it the preferred used for patients with metal sensivity.

TGA Public Summary