(55 days)
Indications for Persona Partial Knee System:
The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:
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Noninflammatory degenerative joint disease (NIDJ), e.g., osteoarthritis, avascular necrosis;
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traumatic arthritis;
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previous tibial condyle or plateau fractures with loss of anatomy or function;
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varus deformities; and
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revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.
The Persona Partial Knee System is a single use implantation with bone cement.
Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ):
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Osteoarthritis, traumatic arthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
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The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).
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History of patellar dislocation or patella fracture.
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Dysplasia-induced degeneration.
These indications will be used for the combined medial and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions.
Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.
The Persona Partial Knee (PPK) system is a partial knee replacement system for the medial compartment of the knee and is modular in design consisting of three implant components:
- Unicondylar Cobalt-Chromium-Molybdenum (Co-Cr-Mo) alloy Femoral components
- Unicondylar Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE) Articular surfaces
- Unicondylar Titanium (Ti-6Al-4V) alloy Tibial components
The Persona Partial Knee System includes surgical instrumentation that facilitate implantation of the above described implant components.
The purpose of this submission is to 1) introduce an alternate surgical technique for proximal tibial resection, accomplished via the introduction of new tibial cut guides and recutters; 2) introduce a new peg drill for preparation of tibial bone; all of which are intended to be used specifically with the Persona Partial Knee system and 3) reclassify the existing tibial cut guides, recutters and the peg drill used with various partial knee systems as Class II devices.
I am sorry, but based on the text provided, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.
The document is a 510(k) premarket notification letter from the FDA regarding the "Persona Partial Knee System." It primarily focuses on:
- Indications for Use: What the device is intended for.
- Device Description: The components and general nature of the knee system.
- Comparison to Predicate Device: Arguing for "substantial equivalence" to a previously approved device (K161592).
- Summary of Performance Data (Nonclinical and/or Clinical): This section lists types of non-clinical tests performed (e.g., simulated use verification, cadaveric design validation, biocompatibility assessment) but does not provide any specific acceptance criteria, reported device performance metrics, or details of the studies themselves. It explicitly states, "Clinical data was not deemed necessary to establish substantial equivalence between the subject and predicate devices."
Therefore, the requested information, such as specific acceptance criteria values, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, or how ground truth was established for training and test sets, is not present in the provided text.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.