Zimmer Biomet has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Persona SoluTion porous plasma spray (PPS) femur. The total knee implant presents an alternative for patients who have sensitivities to bone cement and/or metal.

Persona SoluTion PPS Femur features a porous coating for cementless fixation and has a proprietary surface treatment that the company said enhances wear performance.

Hypersensitivity to metal is a challenge for certain patients related to a traditional cemented total knee replacement (TKR) with an implant made of cobalt-chrome (Co-Cr-Mo) alloy. When exposed to certain metals, people with these hypersensitivities can experience an inflammatory response, pain, and implant loosening that can require a revision TKR.

Zimmer Biomet said its PPS coating offers initial scratch fit stability and supports biological fixation via bony ingrowth. When combined with Persona OsseoTi tibia and Vivacit-E Highly Crosslinked Polyethylene (HXLPE), the total knee implant is designed to minimize the most common metal sensitizers (nickel, cobalt, and chromium) likely to elicit an immune response and is made of a proprietary Tivanium (Ti-6Al-4V) alloy.

The Tivanium alloy is treated with the Ti-Nidium Surface Hardening Process and is compatible with Vivacit-E HXLPE articular surfaces. The Persona Solution PPS femur combined with a Vivacit-E bearing demonstrates similar wear performance compared to Persona cobalt chromium alloy femur coupled with a Vivacit-E bearing, according to the company.

Persona SoluTion PPS Femur will become available in the U.S. in Q1 2025.

“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,” said Joe Urban, President, Knees at Zimmer Biomet. “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.”