Device Dossier

NexGen® Complete Knee Solution Rotating Hinge Knee Tibial Component, Precoat - Uncoated knee tibia prosthesis, metallic

Device Dossier for NexGen® Complete Knee Solution Rotating Hinge Knee Tibial Component, Precoat - Uncoated knee tibia prosthesis, metallic (Uncoated knee…

Intended purpose

Tibial component of the NexGen Rotating Hinge Knee prosthesis system intended to repair or replace the tibial knee joint, for patients with mderate to severe knee instability, significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle, valgus, varus, or flexion deformities, the salvage of previously failed surgical attempts.

Functional description

Modular Tibial component of the NexGen Rotating Hinge Knee prosthesis system intended for flexion/extension and internal/external rotation between the femoral and tibial components, but is constrained in the anterior/posterior and medial/lateral directions by means of a femoral hinge post extension. Tibial components are made from Zimaloy® Cobalt-Chromium-Molybdenum alloyand are for cemented use only.

TGA Public Summary