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 Exactech, Inc..