Wara Samar
12th March 2025
Zimmer Biomet Secures FDA 510(k) Clearance for New Revision Knee Implant
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Zimmer Biomet’s Persona Revision SoluTion Femur, a new component within the Persona Revision Knee System designed to address the needs of patients with sensitivities to certain metals. The latest addition expands the company’s revision knee portfolio by incorporating a surface-hardening treatment aimed at enhancing wear performance.
Advanced Materials and Design
The Persona Revision SoluTion Femur is constructed using Zimmer Biomet’s proprietary Tivanium alloy, which has been in clinical use for over 17 years. The Ti-Nidium Surface Hardening Process further strengthens the material while offering resistance to particle release. This innovation provides surgeons with an alternative option for patients who may be sensitive to commonly used metals, including nickel, cobalt, and chromium.
As part of the Persona Revision Knee System, the implant is designed to offer a personalized fit across primary, partial, and revision knee arthroplasty procedures. It features an array of anatomic components, including tibial and femoral cones, as well as multiple stem choices to support zonal fixation. In addition, the revision femur component is available in both standard and plus sizes, catering to flexion instability and soft tissue balancing while minimizing implant overhang.
Market Availability and Strategic Expansion
Zimmer Biomet has scheduled commercial availability of the Persona Revision SoluTion Femur in the US for the third quarter of this year.
The FDA clearance follows Zimmer Biomet’s recent strategic moves to expand its portfolio. In January 2025, the company announced a definitive agreement to acquire Paragon 28 in a $1.2 billion deal, reinforcing its presence in the foot and ankle market.
Houston, We’re Touching Down!
MedTech World is making its US debut in Houston on March 13, and you won’t want to miss it! As we set our sights on expanding into the US, we’re excited to connect with innovators, industry leaders, and collaborators who share our vision for the MedTech industry.
Join us at Levit Green – Conference Center, Floor 1, 6420 Levit Green Boulevard, Houston, for an opportunity to meet our team, explore partnership possibilities, and be part of this milestone. Reach out at [email protected]!
