Device Dossier

balanSys cemented PS femur - Prosthesis, internal, joint, knee, femoral component

Device Dossier for balanSys cemented PS femur - Prosthesis, internal, joint, knee, femoral component (Prosthesis, internal, joint, knee, femoral…

Intended purpose

A cemented posterior stabilised femoral component which is part of the balanSys knee system, which enables anatomical knee replacement and the treatment of degenerative or post-traumatic arthrosis, failed surface replacement (e.g. infection, loosening etc), fracture or avascular necrosis of the knee joint, correction of varus, valgus or flexion malpositioning and rheumatoid arthritis. It is designed specifically to enable maximum motion, reinstatement of the normal alignment of the leg and stable fixation of the component.

Functional description

The cemented posterior stabilised femoral component is made from cobalt chrome and features a multi radius design with one continuous radius in the main articulation area. this design allows an identical extension and flexion gap between -20 degrees and 90 degrees and requires a minimal bone resection of only 9mm off the distal and posterior condyles. The femoral design also ensures optimal stability and congruency throughout the full range of motion.

TGA Public Summary