510(k) K262251

ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) by Globus Medical, Inc. — Product Code JWH

K262251 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)". The FDA issued a decision of Substantially Equivalent on July 31, 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. Globus Medical, Inc. has at least 10 other 510(k) clearances on record.