(60 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. ﻴﻴﻴ
- 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.
This device is intended for cemented use only.
The Persona Natural Tibia Baseplate is designed to replace the proximal portion of the tibia via cemented fixation as part of the Persona Personalized Knee System.
This is not an AI medical device. The provided text describes a 510(k) premarket notification for a Persona™ Natural Tibia™ Baseplate and Instrumentation, which is a knee joint prosthesis. The document explicitly states:
"Non-Clinical Performance and Conclusions: The following tests have been completed in support of the changes to the Persona Natural Tibia Baseplate: Fixation Testing, Cantilever Fatigue Testing, Bending Fatigue Testing of the keel and stem extension junction, and Cortical Impingement and Perforation Analysis using a database of computed tomography (CT) segmented tibial bones. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
This means the device's performance was evaluated through non-clinical mechanical and analytical tests, not through studies involving AI or its performance in interpreting medical images or data. Therefore, the requested information regarding acceptance criteria and performance related to AI, ground truth, expert adjudication, or MRMC studies for an AI device is not applicable to this submission.
§ 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.