Device Dossier

NexGen® Complete Knee Solution, CR-Flex, Gender Solutions Female (GSF) Femoral Component, Precoat - Uncoated knee femur prosthesis

Device Dossier for NexGen® Complete Knee Solution, CR-Flex, Gender Solutions Female (GSF) Femoral Component, Precoat - Uncoated knee femur prosthesis…

Intended purpose

CR-Flex Gender Solutions Female precoated femoral components are part of a semi-constrained, non-linked condylar knee system intended to repair or replace the femoral 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

CR-Flex Gender Solutions Female precoated femoral components are part of a semi-constrained, non-linked condylar knee system for use with a functional posterior cruciate ligament. They are designed to address specific anatomic features of the distal femur that can be seen in both male and female patients and are for cemented use. They are made from Zimaloy® Cobalt-Chromium- Molybdenum alloy’.

TGA Public Summary