FDA OKs OrthoPediatrics’ Next-Gen Cannulated Screw System

OrthoPediatrics Corp., a company focused exclusively on advancing the field of pediatric orthopedics, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its next generation Cannulated Screw System for treating smaller stature patients with fractures and fusions.
 
The system was designed in collaboration with pediatric orthopedic surgeons focused on more solutions for treating pediatric patients with fractures. It expands the company’s offering to help treat the unique needs found in pediatric hospitals and is expected to launch in the third quarter of 2019. The new screws are stainless steel and available in 2.5mm, 3.0mm, 3.5mm, 4.0mm, 4.5mm, and 5.5mm sizes. Further, this enhanced system offers an “all-in-one” kit option and is optimized to increase operating room efficiency. 
 
OrthoPediatrics’ executive vice president, David Bailey, stated, “We are pleased with the FDA 510(k) clearance for our next generation cannulated screw system, which allows physicians to better treat smaller statures and patients at a younger age. This is truly innovative as it allows physicians to adequately address the issue when first detected/present, instead of waiting until the child grows to fit the tools available or repurposing adult products. Our engineering teams have been diligently working with a prominent group of surgeons, and we are excited to bring yet another system to market in our quest to partner with pediatric orthopedic surgeons.”