510(k) K151459

Integra Total Ankle Replacement System by Ascension Orthopedics — Product Code HSN

K151459 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics for the device "Integra Total Ankle Replacement System". The FDA issued a decision of Substantially Equivalent on August 31, 2015. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Ascension Orthopedics has at least 10 other 510(k) clearances on record.