510(k) K252454

Kinos Total Ankle System by Restor3D — Product Code HSN

K252454 is an FDA 510(k) premarket notification submitted by Restor3D for the device "Kinos Total Ankle System". The FDA issued a decision of Substantially Equivalent on September 3, 2025. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Restor3D has at least 10 other 510(k) clearances on record.