Zimmer Biomet has received US Food and Drug Administration (FDA) 510(k) clearance for Persona SoluTion Porous Plasma Spray (PPS) Femur knee implant component.
Persona SoluTion PPS Femur is designed to offer an alternative for patients sensitive to bone cement or metal.
The component features a porous coating for cementless fixation and a proprietary surface treatment intended to improve wear performance.
Persona SoluTion PPS Femur provides cementless fixation with a PPS coating that ensures initial scratch fit stability and promotes biologic fixation through bony ongrowth.
When paired with the Persona OsseoTi tibia and Vivacit-E Highly Crosslinked Polyethylene (HXLPE), this total knee implant reduces exposure to common metal sensitisers like nickel, cobalt, and chromium.
It is made from proprietary Tivanium (Ti-6Al-4V) alloy, which has over 17 years of clinical use, and is treated with the Ti-Nidium Surface Hardening Process. It is compatible with Vivacit-E HXLPE articular surfaces.
Warsaw, Indiana-based Zimmer Biomet said that the Persona Solution PPS Femur, combined with a Vivacit-E bearing, shows wear performance comparable to the Persona cobalt chromium alloy femur with a Vivacit-E bearing.
Zimmer Biomet knees president Joe Urban said: “With the FDA clearance of Persona SoluTion PPS Femur, in combination with our Persona OsseoTi Tibia and OsseoTi Patella, we are proud to offer surgeons a fully cementless alternative to cobalt-chrome implants.
“Persona SoluTion PPS Femur combines our latest advances in cementless fixation with decades of proprietary clinical expertise in developing novel materials and surface hardening processes.
“The utility and versatility of our comprehensive and clinically proven Persona Knee System is further enhanced with the addition of this innovative solution that could help surgeons address two potential causes of revision procedures: sensitivities to bone cement and metal.”
The knee implant component is expected to be commercially available in the US in Q1 2025.
Last month, the medical technology company secured the FDA premarket approval application (PMA) supplement approval for the Oxford Cementless Partial Knee implant.
