Device Dossier

NexGen® Complete Knee Solution Prolong™ (HXLPE) CR-Flex Mobile Bearing Articular Surface, Regular Constraint - Prosthesis, knee, internal, insert component

Device Dossier for NexGen® Complete Knee Solution Prolong™ (HXLPE) CR-Flex Mobile Bearing Articular Surface, Regular Constraint - Prosthesis, knee,…

Intended purpose

The articular surface component of the NexGen CR-Flex mobile bearing knee system is indicated 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

Articular surface component of the NexGen® CR Mobile semiconstrained, nonlinked condylar mobile bearing knee prostheses system. They are available in multiple thicknesses to facilitate soft tissue tensioning and joint line restoration and intended for use with a functional posterior cruciate ligament (PCL). Manufactured from Prolong Highly Crosslinked Polyethylene. The device is compatible with femoral components from the NexGen CR, CRA and CR-Flex systems.

TGA Public Summary