Device Dossier

Oxford Partial Knee System Domed Lateral Bearing - Unicondylar knee prosthesis

Device Dossier for Oxford Partial Knee System Domed Lateral Bearing - Unicondylar knee prosthesis (Unicondylar knee prosthesis, Class III, sponsor Zimmer…

Intended purpose

Biomet UK Ltd. knee joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients. Whilst these devices are generally successful in attaining these goals they cannot be expected to withstand the activity levels and loads of normal healthy bone. The indications for use of the joint replacement prostheses include: 1)Osteoarthritis, rheumatoid arthritis or traumatic arthritis 2)Failure of a previous joint replacement procedure 3)Correction of varus, valgus or post-traumatic deformity 4)Correction or revision of unsuccessful osteotomy or arthrodesis.

Functional description

A polyethylene knee bearing designed to be used in the lateral knee compartment with the lateral tibial tray. The bearing has a slightly domed bottom face that is congruent with the matching bioconcaved tibial tray upper face to assist in resisting lateral dislocation during deep flexion.

TGA Public Summary