(90 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 coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplates and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.
The purpose of this submission is for a specification update to the Persona Trabecular Metal tibial component, as well as to introduce new tibial instrumentation unique to the device. These modifications do not change the intended use or fundamental scientific technology of the device.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a knee joint prosthesis (Zimmer® Persona® Personalized Knee System). It describes the device, its intended use, indications for use, and a summary of technological characteristics, stating that clinical data was not deemed necessary.
Therefore, there is no information in this document about:
- Acceptance criteria or reported device performance for an AI/ML or diagnostic device.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
This document pertains to a medical device (knee implant), not a software or AI/ML product.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.