510(k) K261462

LANDMARK Total Knee System by Smith & Nephew, Inc. — Product Code MBH

K261462 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "LANDMARK Total Knee System". The FDA issued a decision of Substantially Equivalent on September 8, 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. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.