Device Dossier

NexGen® CKS PROLONG™ LPS-Mobile Articular Surface with Locking Screw - Prosthesis, knee, internal, insert component

Device Dossier for NexGen® CKS PROLONG™ LPS-Mobile Articular Surface with Locking Screw - Prosthesis, knee, internal, insert component (Prosthesis, knee,…

Intended purpose

The Articular surface, a component of the NexGen LPS Mobile Bearing Knee, 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

Posterior ligament stabilising articular surface component of the NexGen LPS Mobile semiconstrained, nonlinked condylar mobile bearing knee prostheses system. It rotates on a highly polished trunnion on the Fluted Stem Tibial Baseplate and is available in multiple thicknesses to facilitate soft tissue tensioning and joint line restoration. Manufactured from Prolongâ„¢ Ultra high molecular-weight Polyethylene(UHMWPE). The locking screw is made of Zimaloy Cobalt-Chromium-Molybdenum Alloy.

TGA Public Summary