New Device for Pediatric Bone Fractures Clears FDA
WARSAW - Warsaw-based OrthoPediatrics Corp. (Nasdaq: KIDS) received clearance from the U.S. Food and Drug Administration for its next generation Cannulated Screw System. The medical screw is used to mend bone fractures, particularly on smaller stature patients or children.
“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,” said OrthoPediatrics’ Executive Vice President, David Bailey.
The company focuses exclusively on creating pediatric orthopedic products.
OrthoPediatrics will offer the stainless steel screws in 2.5mm, 3.0mm, 3.5mm, 4.0mm, 4.5mm, and 5.5mm sizes. The company says the cannulated screw system comes in an “all-in-one” kit option, making the procedure more efficient in the operating room.
“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,” commented Bailey.
The company expects to launch the new product in the third quarter of 2019.