Device Dossier

Persona® Revision Vivacit-E® Highly Crosslinked Polyethylene Articular Surface Fixed Bearing Constrained Condylar Knee (CCK) - Prosthesis, knee, internal, insert component

Device Dossier for Persona® Revision Vivacit-E® Highly Crosslinked Polyethylene Articular Surface Fixed Bearing Constrained Condylar Knee (CCK) -…

Intended purpose

The Persona Revision Vivacit-E Articular Surface CCK is a component of the Persona Revision Knee System, which is a constrained revision knee prosthesis system. 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 Persona Revision CCK Articular Surface is made of Vitamin-E blended polyethylene and includes a Tivanium® insert and lockdown screw. The anterior region of both articular surface condyles is upswept, intended to resist posterior subluxation of the tibia in knee extension, before the cam engages the spine. Designed anatomic to suit the tibial trays. They are offered in 5 sizes corresponding to the compatible tibial components (AB-J), and in thickness ranging from 10-26mm in 2mm increments.

TGA Public Summary