FDA Clears OrthoPediatrics’ Scoliosis System

The FDA granted 510(k) clearance to OrthoPediatrics’ Response 4.5/5.0mm system for treating complex scoliosis in younger patients of smaller stature.

The clearance expands the pediatric orthopedic devicemaker’s Response platform, enabling it to treat smaller patients. It allows the surgeon to choose between a 4.5mm CoCr rod or a 5.0mm titanium or cobalt chromium/chrome rod.

OrthoPediatrics expects to launch the system in the fourth quarter of 2018.