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Zimmer Biomet Lands FDA Clearance

Wednesday, January 3, 2018 05:53 PM EDT Updated: Thursday, January 4, 2018 10:00 AM EDT
By Alex Brown
Zimmer Biomet Lands FDA Clearance The Sidus system debuted in Europe in 2012.

Warsaw-based Zimmer Biomet Holdings Inc. (NYSE: ZBH) has cleared a key hurdle for a shoulder replacement system. The U.S. Food and Drug Administration has given clearance for the medical device company’s Sidus Stem-Free Shoulder system.

Zimmer Biomet says Sidus is designed to benefit eligible shoulder surgery patients with a less invasive surgery, bone preservation and a more personalized fit, according to the company’s website.

"The FDA clearance of the Sidus Stem-Free Shoulder system comes at a time when Zimmer Biomet is accelerating the pace of innovation," said Bryan Hanson, chief executive officer of Zimmer Biomet. "We launched Sidus in Europe in 2012 and initiated a clinical study in the U.S. in 2015. During that time, the product has demonstrated strong clinical performance."

Now that it has received FDA clearance, Zimmer Biomet says the system will be available in the United States in the first quarter of 2018.

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See the unseen: The silent crisis of youth homelessness in central Indiana

See the unseen: The silent crisis of youth homelessness in central Indiana

It is a startling fact that an estimated 7,800 youth experience homelessness in our city every year. These aren't just statistics; they represent the lives of young people, each with a story, a dream, and the potential to thrive if given the opportunity. The shock factor lies in the magnitude of this issue – the magnitude of despair, isolation, and uncertainty that thousands of our city's youth grapple with daily....

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