Device Dossier

NexGen® Complete Knee Solution, Cruciate Retaining (CR) Stemmed Tibial Component - Prosthesis, knee, internal, insert component

Device Dossier for NexGen® Complete Knee Solution, Cruciate Retaining (CR) Stemmed Tibial Component - Prosthesis, knee, internal, insert component…

Intended purpose

Cruciate ligament retaining(CR) stemmed tibial component of the NexGen semiconstrained, nonlinked condylar knee prosthesis system 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 at the time of Surgery.

Functional description

Cruciate ligament retaining(CR) stemmed tibial component of the NexGen semiconstrained, nonlinked condylar knee System. It is made from Ultra-High Molecular Weight Polyethylene and indicated for cemented use only.

TGA Public Summary