Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)

The Persona Personalized Knee System with Porous Plasma Spray (PPS) Femurs is a semi-constrained modular knee prosthesis designed to resurface the articulating surfaces of the femoral, tibial, and patellar bones in patients with severe knee pain and disability from arthritis, collagen disorders, avascular necrosis, or failed prior surgical attempts. The femoral components articulate against the tibial and patellar components as part of a total knee system and come in various sizes to match patient anatomy.

Both the subject and predicate devices are porous plasma sprayed (PPS) femoral components with identical articulating geometry and the same technological characteristics. The only change in this submission is the addition of a new PPS coating supplier for the Persona PPS Femurs, which does not alter the intended use, design, or fundamental scientific technology of the device.

Not stated in this summary. The document lists non-clinical testing such as fatigue testing (cantilever loading and three-point bend), design verification, product requirements evaluation, and microstructural characterization of the PPS coating, but does not cite specific ISO, IEC, or ASTM standards.