Zimmer Biomet(ZBH) Prnewswire·2025-03-07 12:30Core Viewpoint - Zimmer Biomet Holdings, Inc. has received FDA 510(k) clearance for the Persona® Revision SoluTion™ Femur, a knee implant designed for patients with metal sensitivities, marking a significant advancement in the revision knee implant market [1][2]. Product Details - The Persona Revision SoluTion Femur is part of the Persona Revision Knee System and utilizes a proprietary surface-hardening treatment to enhance wear performance [1][2]. - This new implant is made from a proprietary Tivanium® (Ti-6Al-4V) alloy, which has over 17 years of clinical use, and is treated with the Ti-Nidium Surface Hardening Process to improve material strength and wear resistance [2][3]. - The implant will be available in standard and plus sizes to accommodate various patient needs, particularly addressing flexion instability and soft tissue balancing [2][3]. Market Context - Metal hypersensitivity affects 10-15% of the general population, with prevalence in patients with metallic implants reaching up to 25%, indicating a significant market need for alternatives to traditional metal implants [2][3]. - The Persona Revision SoluTion Femur is positioned as the first metal alternative option for patients with sensitivities to common metal allergens such as nickel, cobalt, and chromium [2][3]. Company Overview - Zimmer Biomet is recognized as a global leader in medical technology, focusing on maximizing mobility and improving health through innovative products and integrated digital technologies [3][4]. - The company has a legacy of over 90 years in the industry, emphasizing a culture of evolution and innovation to deliver high-quality solutions [4].