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.

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