FDA cleared the LANDMARK Total Knee System from Smith & Nephew, Inc. on Sep 8, 2026 under K261462, a traditional 510(k). The device falls under product code MBH, Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, regulated at 21 CFR 888.3565 as a Class 2 device. The review panel was Orthopedic.
FDA logged the submission as received on May 4, 2026. The decision came 127 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Smith & Nephew, Inc. has 7 other decisions in the tracker over the last 12 months: K261982 (RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)), K263348 (Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINIT), K261338 (RENASYS DYNAFLOW Kit (66807741)), K261968 (Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)).