Device Dossier

NexGen® Complete Knee Solution, Stemmed Tibial Component Precoat A/P Wedged - Coated knee tibia prosthesis

Device Dossier for NexGen® Complete Knee Solution, Stemmed Tibial Component Precoat A/P Wedged - Coated knee tibia prosthesis (Coated knee tibia…

Intended purpose

Intended to repair or replace the tibial knee joint, 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

Stemmed Anterior/Posterior (A/P) wedged precoated tibial component of the The NexGen® semiconstrained, nonlinked condylar knee system. It is made from Tivanium® Ti-6Al-4V alloy and indicated for cemented use only.

TGA Public Summary