FDA clears revision knee implant from Zimmer Biomet

 Zimmer Biomet (NYSE: ZBH)

 announced today that it received FDA 510(k) clearance for its Persona Revision SoluTion Femur.

The revision knee implant component — part of the comprehensive Persona Revision Knee System — offers an alternative for patients with sensitivities to certain metals.  It leverages a proprietary surface-hardening treatment designed to enhance wear performance. It delivers surgeons an array of anatomic components, including tibial and femoral cones with various stem choices to address zonal fixation.

Warsaw, Indiana-based Zimmer Biomet made its implant solely from a proprietary Tivanium (Ti-6Al-4V) alloy. The alloy has more than 17 years of clinical use backing it. Treated with the Ti-Nidium surface-hardening process, the alloy strengthens to demonstrate hardness comparable to that of metal implants. However, it delivers enhanced wear performance with resistance to particle release.

Zimmer Biomet offers the new revision femur in standard and plus sizes to address flexion instability and soft tissue balancing. It also minimizes implant overhang.

The company plans to make the Persona Revision SoluTion Femur commercially available in the U.S. in the third quarter of 2025.

“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,” said Joe Urban, president, Knees at Zimmer Biomet. “We are proud to offer a total revision knee construct with no deliberate addition of the most common metal allergens (Nickel, Cobalt, & 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.”

https://www.massdevice.com/fda-clears-revision-knee-implant-zimmer-biomet/