Device Dossier

NexGen® Complete Knee Solution, CR Articular Surface, Regular Constrained, With Locking Screw - Prosthesis, knee, internal, insert component

Device Dossier for NexGen® Complete Knee Solution, CR Articular Surface, Regular Constrained, With Locking Screw - Prosthesis, knee, internal, insert…

Intended purpose

The Regular Constrained Articular Surface with Locking Screw of the NexGen CR/CRA/CR-Flex System is indicated for patients with severe knee pain and disability doe 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

Regular constrained, cruciate ligament retaining articulating surface component of the NexGen® semiconstrained, nonlinked condylar knee prostheses system available in multiple thicknesses to facilitate soft tissue tensioning and joint line restoration. 17 and 20mm 90 prefix CR articular surfaces require a locking screw (manufactured from Tivanium Ti-6Al-4V alloy) to fasten the articular surface to the tibial baseplate. It is made from Ultra-High Molecular Weight Polyethylene (UHMWPE).

TGA Public Summary