FDA Product Code HTN: Washer, Bolt Nut

FDA product code HTN covers washers, bolts, and nuts used as components of orthopedic fixation constructs.

These hardware components provide load distribution, locking, and mechanical interface functions within complex fracture fixation systems. They are used in conjunction with bone screws, plates, and rods to create stable constructs for the treatment of complex fractures and deformities.

HTN devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., TriMed, Inc. and Vilex, LLC.