Device Dossier

SCORE II Femoral Component Cemented - Uncoated knee femur prosthesis

Device Dossier for SCORE II Femoral Component Cemented - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor Amplitude).…

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 device is designed to cover the distal part of the femur and is made of Chrome-Cobalt alloy. The exterior surface is mirror polished. Fixation to the bone is with the use of bone cement and the inner part of the box is shot blast. The femoral box has a thickness of at least 8mm whatever the size. The design presents a sagittal and frontal congruence with the tibial insert. The deep trochlea centres the patella and in the sagittal plane the condyle shape is a series of three curvatures.

TGA Public Summary