FDA Product Code HSN: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Total ankle replacement has gained significant momentum as an alternative to arthrodesis. FDA product code HSN covers semi-constrained cemented ankle prostheses with metal-polymer bearing surfaces.
These three-component implants replace the tibial plafond and talar dome surfaces to restore pain-free ankle motion while preserving the natural kinematics of the joint. They offer improved gait compared to ankle fusion in appropriately selected patients with end-stage ankle arthritis.
HSN devices are Class II medical devices, regulated under 21 CFR 888.3110 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Paragon 28, Inc., Restor3d and Wrightmedicaltechnologyinc.
FDA 510(k) Cleared Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer Devices (Product Code HSN)
About Product Code HSN - Regulatory Context
510(k) Submission Activity
67 total 510(k) submissions under product code HSN since 1976, with 67 receiving FDA clearance (average review time: 129 days).
Submission volume has remained relatively stable over the observed period, with 8 submissions in the last 24 months.
FDA Review Time
Recent submissions under HSN have taken an average of 111 days to reach a decision - down from 132 days historically, suggesting improved FDA processing for this classification.
HSN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →