(41 days)
This device 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 ratellofemoral 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.
This device is intended for cemented use only.
The NexGen MIS Modular Tibial Plates and Keels are part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses.
The provided text is a 510(k) summary for the Zimmer NexGen MIS Modular Tibial Plates and Keels. It is a premarket notification for a medical device seeking clearance based on substantial equivalence to a predicate device, not a study reporting on the device's performance against specific acceptance criteria.
Therefore, the document does not contain the information required to populate the requested table about acceptance criteria, device performance, or details about a study proving the device meets those criteria.
Specifically, the document states:
- Performance Data (Nonclinical and/or Clinical): "Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device."
- Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."
This indicates that the Zimmer NexGen MIS Modular Tibial Plates and Keels were cleared based on design assurance performance testing and substantial equivalence to a previously cleared predicate device (NexGen Complete Knee Solution, K933785, cleared January 30, 1995), not on clinical studies with specific acceptance criteria as you've requested. The modifications from the predicate device were considered minor and not to change the intended use or fundamental scientific technology.
§ 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.