Device Dossier
NexGen® Complete Knee Solution Legacy® Knee Posterior Stabilized PROLONG™ XLPE LPS-Flex Articular Surface W/Insert & Locking Screw - Prosthesis, knee, internal, insert component
Device Dossier for NexGen® Complete Knee Solution Legacy® Knee Posterior Stabilized PROLONG™ XLPE LPS-Flex Articular Surface W/Insert & Locking Screw -…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The NexGen® Complete Knee Solution Legacy® Knee PROLONG™ Highly Crosslinked Polyethylene LPS-Flex Articular Surface W/Insert and Locking Screw is 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
Articular surface component of the NexGen® Flex fixed bearing system semiconstrained, nonlinked condylar knee prostheses system. It is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. Compatible with the NexGen LCCK system. Made of Prolong™ highly crosslinked ultra-high molecular weight polyethylene (XLPE). This device also comes with an insert and locking screw, both manufactured from Tivanium Ti6AI4V.