(93 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 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.
Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.
The purpose of this submission is to add a new component to the Persona Revision Knee System, the component is the Persona Revision SoluTion Femoral Components. The addition of these components do not change the intended use or fundamental scientific technology of the device system.
The Persona Revision Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral and tibial bones. With this submission a new Ti-6Al-4V femoral component will be added to the system. These femoral components articulate against an articular surface of the tibial component, as well as, a pat of a total knee system. The new femoral components are compatible with a variety of augments, cones, and stem extent of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.
This document is a 510(k) Premarket Notification from the FDA regarding the "Persona® Revision Knee System (Persona Revision Solution™ Femoral Components)." It does not contain acceptance criteria for a study, nor does it present the results of a study to demonstrate that a device meets such criteria.
Instead, this document is a notification of the FDA's decision that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a review of information provided by the manufacturer, Zimmer, Inc., which includes a summary of non-clinical tests performed.
The relevant section, "Non-Clinical and/or Clinical Tests Summary & Conclusions" on page 5, lists several non-clinical tests that were performed (e.g., fatigue evaluations, wear evaluation, constraint assessment, augment shear and torque, stem junction fatigue, stem static axial pull-off and torque-off, RF-induced heating simulations, fretting corrosion assessment).
However, for each of these tests, the document only lists the test name. It does not provide:
- Acceptance criteria: What performance metrics were deemed acceptable for each test.
- Reported device performance: The actual results obtained from these tests.
- Study details: Such as sample sizes, data provenance, ground truth establishment, or any information related to expert involvement (for clinical studies, which are explicitly stated as "Not Applicable" here).
- Comparative effectiveness study (MRMC) or standalone performance: These are not discussed as the tests are non-clinical.
In summary, the provided document explicitly states "Clinical Testing Not Applicable" and lists non-clinical tests without presenting their results or acceptance criteria. Therefore, it is not possible to provide the requested information.
§ 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.