OrthoPediatrics Lands FDA Clearance
Mark Throdahl is CEO of OrthoPediatrics. (photo courtesy Nasdaq)
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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowWarsaw-based OrthoPediatrics Corp. (Nasdaq: KIDS) has received clearance from the U.S. Food and Drug Administration for its newest surgical system. The company says the RESPONSE System is designed to treat smaller stature young patients with complex scoliosis.
OrthoPediatrics says the 510(k) clearance from the FDA will allow it to launch the surgical system in the fourth quarter. The RESPONSE 4.5/5.0mm System allows physicians to better treat smaller statures and patients at a younger age, according to OrthoPediatrics Executive Vice President David Bailey.
"Our engineering teams have been diligently working with a prominent group of surgeons, and we are excited to bring their innovative vision to life with another surgical solution for treating complex pediatric scoliosis," said Bailey. "The addition of the new system to our scoliosis platform continues to demonstrate OrthoPediatrics’ focus and commitment to providing solutions for children with complex spinal disorders."
You can learn more about the system, which is the company’s 26th surgical system, by clicking here.
Earlier this year, the medical device manufacturer announced plans to invest $1 million to expand its Kosciusko County headquarters by more than doubling is existing warehouse space and adding office space and dedicated training and education facilities.