510(k) K253328

GMK 3D Metal Tibial Tray Extension by Medacta International S.A. — Product Code MBH

K253328 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "GMK 3D Metal Tibial Tray Extension". The FDA issued a decision of Substantially Equivalent on February 26, 2026. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Medacta International S.A. has at least 10 other 510(k) clearances on record.