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., Vilex, LLC and Acumed, LLC.
FDA 510(k) Cleared Washer, Bolt Nut Devices (Product Code HTN)
About Product Code HTN - Regulatory Context
510(k) Submission Activity
92 total 510(k) submissions under product code HTN since 1984, with 92 receiving FDA clearance (average review time: 111 days).
Submission volume has increased in recent years - 10 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for HTN submissions have been consistent, averaging 114 days recently vs 110 days historically.
HTN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →