Zimmer Biomet Gains FDA Clearance for Persona Revision SoluTion Femur

Zimmer Biomet was granted FDA 510(k) clearance to market Persona Revision SoluTion Femur, a revision knee implant component offering an alternative for patients with sensitivities to certain metals. The device is slated for U.S. launch in 3Q25.

SoluTion Femur, part of the Persona Revision Knee System, leverages a proprietary surface-hardening treatment designed to enhance wear performance, which offers surgeons an array of anatomic components, including tibial and femoral cones with various stem choices to address zonal fixation.

The Persona Revision SoluTion Femur is made solely of a proprietary Tivanium (Ti-6Al-4V) alloy with more than 17 years of clinical use. The alloy is treated with the Ti-Nidium Surface Hardening Process, which results in a strengthened material that demonstrates hardness, comparable to that of metal implants, with enhanced wear performance that provides resistance to particle release. The new revision femur is offered in standard and plus sizes to address flexion instability and soft tissue balancing while minimizing implant overhang.

“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.”

Source: Zimmer Biomet