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 Paragon 28, Inc..
List of Rod, Fixation, Intramedullary And Accessories devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Rod, Fixation, Intramedullary And Accessories devices (product code HSB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →