Device Dossier
PROLONG™ Highly Crosslinked Polyethylene NexGen® Complete Knee Solution, CR Articular Surface - Prosthesis, knee, internal, insert component
Device Dossier for PROLONG™ Highly Crosslinked Polyethylene NexGen® Complete Knee Solution, CR Articular Surface - Prosthesis, knee, internal, insert…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
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
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 Prolong™ Highly Crosslinked Polyethylene (HXPE) material.