The FDA has granted 510(k) clearance to Wishbone Medical’s Smart Correction external fixation system, a device used for the fusion of long bones in pediatric patients.

The system, which includes software for surgical planning, is intended for treating open and closed fractures, joint fusion and unsuccessful spinal fusion, as well as limb lengthening, deformity and angular correction, and malunions in pediatric patients.

The company said it plans to transition the system to a single-use, sterile-packed procedure kit.