Device Dossier
NexGen® Complete Knee Solution CR-Flex Femoral Component, Precoat - Uncoated knee femur prosthesis
Device Dossier for NexGen® Complete Knee Solution CR-Flex Femoral Component, Precoat - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis,…
- GMDN category: Uncoated knee femur prosthesis
Intended purpose
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
Semi constrained, non-linked condylar knee CR-Flex femoral components designed to have a maximum active flexion of 155 degrees. They are made from Zimaloy® Cobalt-Chromium- Molybdenum alloy/ PMMA and is indicated for cemented use. Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. Pre coated with hydroxyapatite/tricalcium phosphate(HA/TCP).