FDA 510(k)

LANDMARK Total Knee System

K-Number: K261462 · 2026-09-08

Decision Date2026-09-08

Product CodeMBH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LANDMARK Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2026-09-08 under 510(k) number K261462. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LANDMARK Total Knee System?

LANDMARK Total Knee System is a medical device that received FDA 510(k) clearance on 2026-09-08. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K261462.

When did LANDMARK Total Knee System receive FDA 510(k) clearance?

LANDMARK Total Knee System received FDA 510(k) clearance on 2026-09-08, under 510(k) number K261462.

Who is the listed applicant for LANDMARK Total Knee System?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LANDMARK Total Knee System?

The FDA product code for LANDMARK Total Knee System is MBH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02440672JOURNEY™ II CR Total Knee SystemACTIVE_NOT_RECRUITING NCT04849884To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.COMPLETED NCT07199738A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)RECRUITING NCT03247023Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint ReplacementTERMINATED NCT03985839Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and HipCOMPLETED NCT04325022Safety and Effectiveness Study of OR3O™ Dual Mobility System in THAACTIVE_NOT_RECRUITING

Other records listing Smith & Nephew, Inc. as applicant

K261968Q-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)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: MBH)

K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.