Device Dossier

PERSONA™, The Personalized Knee System, Femur, Cemented, Posterior Stabilized (PS) - Uncoated knee femur prosthesis

Device Dossier for PERSONA™, The Personalized Knee System, Femur, Cemented, Posterior Stabilized (PS) - Uncoated knee femur prosthesis (Uncoated knee…

Intended purpose

The Posterior Stabilized (PS) Femur is a component of Persona™, The Personalized Knee System, a semiconstrained total knee prosthesis. This device is indicated for patients with severe knee pain and disability due to: • Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Collagen disorders, and/or avascular necrosis of the femoral condyle. • Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. • Moderate valgus, varus, or flexion deformities. • The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Functional description

The PS femoral component is made from Zimaloy® CoCrMo alloy. It is used with PS articular surfaces when both cruciate ligaments are excised or for use with CPS articular surfaces when both cruciate ligaments are excised, moderate varus/valgus constraint is needed and stems and augments are not required. Active flexion ranges from 135-155 degrees depending on the articular surface component used. The narrow components have a smaller ML aspect ratio. Intended for cemented use only.

TGA Public Summary