Zimmer Biomet (ZBH) said Friday that the US Food and Drug Administration has given 510(k) clearance of its Persona Revision SoluTion Femur knee implant component for patients sensitive to certain metals.
The component, made with Tivanium alloy, would be available in the US in Q3, according to the company. It is part of its Persona Revision Knee System which offers surgeons a variety of anatomic replacements, Zimmer Biomet said.
Metal hypersensitivity affects up to 15% of the general population, the company said.
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