Device Dossier

NexGen® Complete Knee Solution Rotating Hinge Knee (RHK), Femoral Component, Option - Uncoated knee femur prosthesis

Device Dossier for NexGen® Complete Knee Solution Rotating Hinge Knee (RHK), Femoral Component, Option - Uncoated knee femur prosthesis (Uncoated knee…

Intended purpose

Femoral component of the NexGen Rotating Hinge Knee prosthesis system intended for patients with moderate 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

Femoral 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. Manufactured from Zimaloy® Cobalt-Chromium-Molybdenum alloy. For cemented use only.

TGA Public Summary