(82 days)
When a mechanical alignment approach is utilized, 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.
When a kinematic alignment approach is utilized, 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.
- Moderate valgus, varus, or flexion deformities.
The kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.
Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, stem extension, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.
The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Personalized Knee System includes surgical instrumentation that facilitate implantation of the above described implant components.
The purpose of this submission is the introduction of an optional alternative surgical technique for distal femoral resection that enables for gap balancing and femoral external rotation, accomplished via the use of a new instrument platform including a femoral rotation guide and anterior-posterior cutting blocks. The resection of the proximal tibia is performed in accordance with the standard Persona Primary Knee Surgical Technique.
The new instruments do not change the intended use or fundamental scientific technology of the Persona Personalized Knee System components.
This document describes the 510(k) premarket notification for the Zimmer Persona® Personalized Knee System, focusing on the introduction of an optional alternative surgical technique and new instrumentation. It is a submission for a Class II medical device (knee prosthesis).
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.
The submission is for a knee prosthesis and associated surgical instrumentation. The "Performance Data" section explicitly states:
- Non-Clinical Performance and Conclusions:
- Biocompatibility assessment
- Cadaveric design validation
- Design Verification Modular Brackets
- Clinical Performance and Conclusions:
- Clinical data and conclusions were not needed for this device.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device, as this document pertains to a traditional medical device (knee implant and instruments) that did not require clinical data or AI/ML performance evaluation for its 510(k) clearance.
§ 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.