FDA Product Code HSB: Rod, Fixation, Intramedullary And Accessories

FDA product code HSB covers intramedullary rods and their accessories.

These load-sharing implants are inserted into the medullary canal of long bones — such as the femur, tibia, and humerus — to stabilize diaphyseal fractures and correct deformities. Intramedullary nailing is the standard of care for most femoral and tibial shaft fractures.

HSB devices are Class II medical devices, regulated under 21 CFR 888.3020 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Stryker GmbH, Arthrex, Inc. and Orthofix Srl.