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., Wrightmedicaltechnologyinc and Exactech, Inc..
List of Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer devices (product code HSN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →