Device Dossier
NexGen® Complete Knee Solution, Stemmed Tibial Component, Precoat - Coated knee tibia prosthesis
Device Dossier for NexGen® Complete Knee Solution, Stemmed Tibial Component, Precoat - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class…
- GMDN category: Coated knee tibia prosthesis
Intended purpose
The NexGen Stemmed Tibial Component, Precoat is a semiconstrained, nonlinked condylar knee prosthesis 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
The device is a stemmed tibial component of the NexGen® semiconstrained, nonlinked condylar knee system. The NexGen stem base is designed to resist base plate lift-off due to tilting that can result from poor bone stock. It is manufactured from Tivanium® Ti?6Al?4V alloy with a PMMA precoat. For use with or without a stem extension. In the absence of a stem extension, the distal stem taper is capped with a preassembled modular UHMWPE plug. Indicated for cemented use only.