Device Dossier

PERSONA™, The Personalized Knee System, Natural Tibia, Cemented, 5 Degree, Stemmed - Uncoated knee tibia prosthesis, metallic

Device Dossier for PERSONA™, The Personalized Knee System, Natural Tibia, Cemented, 5 Degree, Stemmed - Uncoated knee tibia prosthesis, metallic…

Intended purpose

Tibial 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

Tibial component of Persona™, The Personalized Knee System, a semiconstrained total knee prosthesis. Manufactured from Tivanium® Ti-6Al-4V alloy. The asymmetric stemmed tibial component is available in left and right configurations with multiple Medial/Lateral sizes. It provides a secure locking interface for Persona™ articular surfaces. Intended for cemented use only.

TGA Public Summary