510(k) K262057

GMK Extension by Medacta International SA — Product Code JWH

K262057 is an FDA 510(k) premarket notification submitted by Medacta International SA for the device "GMK Extension". The FDA issued a decision of Substantially Equivalent on September 15, 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. Medacta International SA has at least 10 other 510(k) clearances on record.