510(k) K261458

ATTUNE Total Knee System; ATTUNE Cementless Knee System by DePuy Ireland UC — Product Code JWH

K261458 is an FDA 510(k) premarket notification submitted by DePuy Ireland UC for the device "ATTUNE Total Knee System; ATTUNE Cementless Knee System". The FDA issued a decision of Substantially Equivalent on June 25, 2026. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. DePuy Ireland UC has at least 10 other 510(k) clearances on record.