The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zimmer Biomet's new revision knee implant component, Persona Revision SoluTion Femur, to provide an option for individuals with sensitivities to particular metals.
Using a surface-hardening treatment to improve wear performance, the implant is part of the Persona Revision Knee System.
The implant also features a suite of anatomic components for surgeons, including tibial and femoral cones with several stem choices for addressing zonal fixation.
The Persona Revision Knee System claims to "replicate" the anatomy of a person for an "individualised" fit across primary, partial, and revision knee arthroplasties.
Zimmer's implant is made with proprietary Tivanium alloy, which has been in clinical use for more than 17 years. The Ti-Nidium Surface Hardening Process enhances the material's firmness, offering particle release resistance.
The latest revision femur component is available in standard and plus sizes, for addressing flexion instability and soft tissue balancing, while decreasing the overhang of the implant, stated the company.
Its commercial availability in the US is scheduled in the third quarter of this year.
Zimmer Biomet Knees president Joe Urban said: "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.
"We are proud to offer a total revision knee construct with no deliberate addition of the most common metal allergens (nickel, cobalt, and 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 January 2025, the company signed a definitive agreement to acquire Paragon 28. The $1.2bn deal aims to strengthen Zimmer Biomet's foot and ankle portfolio.
"FDA grants 510(k) clearance to Zimmer's new revision knee implant component" was originally created and published by Medical Device Network, a GlobalData owned brand.