Device Dossier

Score II Mobile Bearing Insert UHMWPE - Prosthesis, knee, internal, insert component

Device Dossier for Score II Mobile Bearing Insert UHMWPE - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component,…

Intended purpose

Device intended for the replacement of the total knee joint in order to reduce pain and restore knee function, and for partial or total revisions treatment of specific total knee prosthesis cases (at the discretion of the surgeon). Total knee arthroplasties are indicated for: - Aseptic osteonecrosis; - Rheumatoid arthritis / inflammatory diseases; - Revising an osteotomy; - Revising total, unicompartmental or femoro-patellar prostheses. - Primary or secondary osteoarthritis;

Functional description

The tibial insert is mobile by rotation over the tibial tray. The upper face, with the two concavities corresponding to the two femoral condyles, allows congruence with the femur, in the frontal and sagittal planes, and in extension. The conic and cylindrical post under the insert matches the corresponding hole in the tray: it avoids dislocation from the tray and applies the constraint to obtain a pure rotational movement. This insert is made from Ultra High Molecular Weight Polyethylene.

TGA Public Summary