FDA Clears Zimmer Persona Knee Implant

FDA has cleared a Zimmer Biomet 510(k) for its Persona Revision SoluTion Femur, a revision knee implant as an alternative for patients with sensitivities to certain metals (nickel, cobalt, and chromium). The device “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 company says.

The Persona is made of a proprietary Tivanium (Ti-6Al-4V) alloy, Zimmer Biomet says. “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,” it says, adding that it comes in standard and plus sizes to address flexion instability and soft tissue balancing.