Zimmer Biomet Lands FDA Clearance
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.