Device Dossier
NexGen® Complete Knee Solution, CR Articular Surface, Regular Constrained - Prosthesis, knee, internal, insert component
Device Dossier for NexGen® Complete Knee Solution, CR Articular Surface, Regular Constrained - Prosthesis, knee, internal, insert component (Prosthesis,…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The Regular Constrained Articular Surface 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. It is made from Ultra-High Molecular Weight Polyethylene (UHMWPE).