Zimmer Biomet Wins FDA Nod for Persona Revision SoluTion Femur

Zimmer Biomet has earned U.S. Food and Drug Administration (FDA) 510(k) clearance of its Persona Revision SoluTion Femur, a revision knee implant component offering an alternative for patients with sensitivities to certain metals.

The implant leverages a proprietary surface-hardening treatment to enhance wear performance, according to the company. It provides surgeons a variety of anatomic components, including tibial and femoral cones with an array of stem choices to address zonal fixation.

The Persona Revision SoluTion Femur is made of a proprietary Tivanium (Ti-6Al-4V) alloy with over 17 years of clinical use. The alloy is treated with the Ti-Nidium surface hardening process, which causes a strengthened material with hardness comparable to metal implants. It also features enhanced wear performance that offers resistance to particle release, Zimmer Biomet said.

The revision femur comes in standard and plus sizes to address flexion instability and soft tissue balancing, which minimizing implant overhang. It will become commercially available in the U.S. in Q3 2025.

“We are pleased to expand our proprietary surface-hardening technology into the revision knee space with FDA clearance of the Persona Revision SoluTion Femur, the first metal alternative option for those with certain metal sensitivities,” said Joe Urban, President, Knees at Zimmer Biomet. “We are proud to offer a total revision knee construct with no deliberate addition of the most common metal allergens (Nickel, Cobalt, & Chromium). Metal sensitivity is one of the potential causes of revision procedures, and the Persona Revision SoluTion Femur is yet another innovation that delivers on our commitment to solve the most meaningful challenges in musculoskeletal health.”

In December, the company gained FDA clearance for the Persona SoluTion porous plasma spray (PPS) femur, another alternative for patients who have sensitivities to bone cement and/or metal.