(30 days)
The NexGen® Primary Porous Patellar components are intended as a patellar component whose indications for use include: 1) Non-inflammatory degenerative disease joint including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, and 5) treatment of that are unmanageable using other fractures techniques. This device is intended for use with bone cement.
The NexGen Primary Porous Patella is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct ultra-high molecular weight compression molded polyethylene (UHMWPE). The Primary Porous Patella is available in two options: 'Micro and Standard. These patellar components are intended for use with Zimmer NexGen Femoral components.
This document is a 510(k) Premarket Notification for the NexGen® Primary Porous Patella and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
It is a regulatory submission demonstrating the device's substantial equivalence to existing legally marketed devices, rather than a clinical study report. Therefore, I cannot extract the requested information from the provided text.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.