Device Category Dossier

Prosthesis, internal, joint, knee, total

Device Category Dossier for Prosthesis, internal, joint, knee, total. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Rotating hinge knee system components are designed for total reconstructive replacement of the knee joint in cases where there is destruction of joint surfaces with or without significant bone deformity. These devices are used when the cruciate and/or collateral ligaments do not adequately stabilise the knee joint, when ligaments are inadequate or musculature is weak, or when revision is required for failed prostheses with gross instability, bone loss, or inadequate soft tissue.