Zimmer Biomet Holdings, Inc, a global leader in medical technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Persona® Revision SoluTion™ Femur. This innovative revision knee implant component offers a metal-sensitive alternative for patients with hypersensitivities to nickel, cobalt, and chromium. Designed as part of the comprehensive Persona Revision Knee System, the Persona Revision SoluTion Femur incorporates a proprietary surface-hardening treatment to enhance wear performance and offers surgeons a range of anatomic components for personalized patient care.

"Metal sensitivity is an important consideration in knee revision procedures, and we are proud to introduce the first revision femur with no deliberate addition of the most common metal allergens," said Joe Urban, President, Knees at Zimmer Biomet. "With the FDA clearance of the Persona Revision SoluTion Femur, we are expanding our proprietary surface-hardening technology into the revision knee space, furthering our commitment to addressing musculoskeletal challenges and improving patient outcomes."

Cutaneous metal hypersensitivity affects up to 25% of patients with metallic implants, potentially triggering inflammatory responses, pain, and implant loosening that may necessitate revision surgery. The Persona Revision SoluTion Femur is made solely of Tivanium® (Ti-6Al-4V) alloy, a material with over 17 years of clinical use. Enhanced through the Ti-Nidium Surface Hardening Process, this alloy offers superior wear performance and resistance to particle release, minimizing complications for metal-sensitive patients.

Available in standard and plus sizes to optimize soft tissue balancing and flexion stability, the Persona Revision SoluTion Femur is set to launch commercially in the U.S. in Q3 2025. This innovation reinforces Zimmer Biomet’s dedication to providing patient-centric solutions that enhance knee implant performance and longevity.