510(k) K240475

Hintermann Series H2 Total Ankle System by Vilex, LLC — Product Code HSN

K240475 is an FDA 510(k) premarket notification submitted by Vilex, LLC for the device "Hintermann Series H2 Total Ankle System". The FDA issued a decision of Substantially Equivalent on December 2, 2024. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Vilex, LLC has at least 10 other 510(k) clearances on record.