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.
FDA 510(k) Cleared Rod, Fixation, Intramedullary And Accessories Devices (Product Code HSB)
About Product Code HSB - Regulatory Context
510(k) Submission Activity
523 total 510(k) submissions under product code HSB since 1977, with 523 receiving FDA clearance (average review time: 118 days).
Submission volume has remained relatively stable over the observed period, with 31 submissions in the last 24 months.
FDA Review Time
Recent submissions under HSB have taken an average of 156 days to reach a decision - up from 115 days historically. Manufacturers should account for longer review timelines in current project planning.
HSB devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →