London, United Kingdom, September 22, 2026

Smith+Nephew has announced U.S. FDA 510(k) clearance for its LANDMARK™ Total Knee System and the completion of the first surgical case using the next-generation knee replacement technology. Designed to support a more personalized approach to total knee arthroplasty (TKA), the LANDMARK system is intended to replicate healthy knee anatomy and support more natural knee motion. The new implant system combines an anatomy-driven design with the capabilities of CORI™ KNEE Handheld Robotics Arthroplasty, giving surgeons tools intended to support patient-specific surgical planning and execution. The first LANDMARK Knee surgical case was completed by Dr. Steven MacDonald, Professor of Orthopaedic Surgery at Western University and London Health Sciences Centre in London, Ontario. The U.S. FDA’s 510(k) database lists LANDMARK Total Knee System under the orthopedic knee prosthesis category, with a substantially equivalent (SESE) clearance decision dated September 8, 2026.

LANDMARK System Designed Around Natural Knee Anatomy

The LANDMARK Total Knee System has been designed to address key anatomical and functional considerations in knee replacement surgery. According to Smith+Nephew, the implant is designed to replicate aspects of healthy knee anatomy and natural motion, while supporting restoration of the anterior-posterior position of the knee with fewer compromises compared with conventional total knee replacement designs. The system features a smooth, flat trochlear groove entry point intended to support more natural patellar tracking throughout the range of motion. Its femoral and tibial components are designed around natural anatomy and the joint line, with the goal of giving surgeons greater flexibility when making patient-specific alignment decisions. The system also incorporates a fully 3D-printed femoral component using CONCELOC™ Technology, adding advanced manufacturing capabilities to the implant platform. These design features are intended to support an increasingly personalized approach to orthopedic surgery while maintaining procedural efficiency.

First Surgical Case Demonstrates Clinical Introduction

The first LANDMARK Knee procedure represents an early clinical milestone following the FDA clearance. Dr. Steven MacDonald, who was involved in the design and development of the implant, performed the initial surgical case in London, Ontario. Smith+Nephew said the system can be used with its CORI KNEE Handheld Robotics Arthroplasty platform, which provides planning and balancing capabilities intended to help surgeons make individualized decisions during total knee replacement. The compact and mobile robotic system is designed for use across both hospital and ambulatory surgery center (ASC) environments, potentially allowing the LANDMARK implant to be incorporated into different surgical settings. Smith+Nephew also identified Dr. Steven Haas, Chief of the Knee Service at Hospital for Special Surgery in New York, as another surgeon involved in development of the LANDMARK Knee. The combination of implant design and robotic assistance reflects the company’s broader focus on personalized orthopedic procedures.

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Smith+Nephew Plans Phased LANDMARK Knee Launch

Following FDA clearance and the initial surgical procedure, Smith+Nephew plans to introduce the LANDMARK Knee through a phased commercial launch, initially focusing on early customer adoption before broader availability across markets is expected throughout 2027. The company plans to showcase the technology to healthcare professionals at the American Association of Hip & Knee Surgeons (AAHKS) Annual Meeting in Dallas in November 2026. The LANDMARK system adds another technology to Smith+Nephew’s orthopedic portfolio, which includes implants, robotic-assisted surgery and other technologies used in joint replacement procedures. The system’s development reflects continued efforts in orthopedic medicine to combine anatomically designed implants, 3D printing and robotic-assisted surgery to support individualized total knee arthroplasty. While FDA 510(k) clearance permits the device to enter the U.S. market for its cleared indications, the announcement of the first surgical case does not by itself establish superior clinical outcomes compared with other knee replacement systems. Broader clinical experience and evidence will be important as the technology moves through its planned commercial rollout.

The LANDMARK milestone represents a significant development in orthopedic medical technology, bringing together an anatomy-focused knee implant, 3D-printed components and handheld robotic-assisted surgery. For the medical-device sector, the system illustrates how manufacturers are increasingly integrating personalized surgical planning with implant design to address anatomical variation in total knee replacement. Smith+Nephew’s planned 2027 broader availability will provide additional opportunities for surgeons to evaluate the technology in routine clinical practice. The company will continue introducing the system through its phased launch while expanding awareness among orthopedic healthcare professionals.

Source: Smith+Nephew press release