Device Category Dossier

Uncoated unicondylar knee tibia prosthesis, metallic

Device Category Dossier for Uncoated unicondylar knee tibia prosthesis, metallic. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Unicompartmental knee implants restore either compartment of a knee affected by noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis, or serve as partial revisions to replace the tibial insert when femoral and tibial components are well-fixed. These single-use devices are intended for implantation only with bone cement and are used in patients with painful or disabling knee joints requiring replacement of a single compartment rather than the entire joint.