510(k) K250641

APEX 3D Total Ankle Replacement System by Paragon 28, Inc. — Product Code HSN

K250641 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "APEX 3D Total Ankle Replacement System". The FDA issued a decision of Substantially Equivalent on May 1, 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. Paragon 28, Inc. has at least 10 other 510(k) clearances on record.