OrthoPediatrics Receives FDA 510(k) Clearance for Small Stature Scoliosis System with 26th Surgical System

OrthoPediatrics (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new RESPONSE 4.5/5.0mm System for treating smaller stature younger patients with complex scoliosis.

As quoted in the press release:

The RESPONSE 4.5/5.0mm System was designed in collaboration with pediatric orthopedic surgeons focused on additional solutions for treating complex pediatric scoliosis patients. It expands the Company’s RESPONSE platform to treat smaller stature children and builds upon the successful implant and instrument technology of the RESPONSE 5.5/6.0mm System. The RESPONSE 4.5/5.0mm System offers a hybrid implant technology allowing the option of either a 4.5mm rod in CoCr or 5.0mm rod in titanium or cobalt chromium/chrome material, multiple implant connector options, and innovative, new instrumentation.

OrthoPediatrics’ Executive Vice President, David Bailey, stated, “We are pleased with the FDA 510(k) clearance for our 4.5/5.0mm system, which allows physicians to better treat smaller statures and patients at a younger age. 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.  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.”

Click here to read the full press release.