Device Dossier

NexGen® Complete Knee Solution Legacy® Knee LPS Femoral Component, Precoat - Uncoated knee femur prosthesis

Device Dossier for NexGen® Complete Knee Solution Legacy® Knee LPS Femoral Component, Precoat - Uncoated knee femur prosthesis (Uncoated knee femur…

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

Porous coated femoral component of the NexGen® semiconstrained, nonlinked condylar knee prostheses system designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. Precoated with poly (methylmethacrylate) [PMMA]. manufactured from Zimaloy® Cobalt-Chromium-Molybdenum alloy and indicated for cemented use only

TGA Public Summary