FDA Clears Smith+Nephew’s LANDMARK Total Knee System

Smith+Nephew has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for the LANDMARK Total Knee System, a next-generation implant designed to replicate healthy joint anatomy and motion, supporting a more personalized approach to total knee arthroplasty.

The LANDMARK System’s regulatory milestone coincided with the product’s OR debut this week in Ontario, Canada.

As expectations for total knee arthroplasty continue to evolve, surgeons and patients are seeking the most advanced, tailored solutions when choosing a knee replacement. The LANDMARK Knee provides such a solution through an anatomy-driven implant that leverages the full capabilities of CORI◊ KNEE Handheld Robotics Arthroplasty.¹ The compact footprint and mobility of Handheld Robotics are optimized for use across both hospital and ambulatory surgery center (ASC) environments.

“It is truly a landmark moment for Orthopaedics at Smith+Nephew. The future of knee replacement is increasingly personalized, and surgeons need technologies that help them deliver individualized care with confidence and efficiency,” Smith+Nephew Orthopaedics President Nate Folkert said. “Together, the natural design of LANDMARK Knee paired with CORI KNEE Handheld Robotics Arthroplasty provides a powerful solution to address the evolving needs of orthopedic surgery.

Key features of the LANDMARK Knee include:  

• Designed to replicate healthy knee anatomy and restore the natural motion and A/P position with less compromise*^2-6
• Smooth, flat trochlear groove entry point to promote more natural patella tracking*^2,7,8
• Fully 3D-printed femoral component using CONCELOC◊ Technology³

The first LANDMARK Knee surgical cases were completed this week by Dr. Steven MacDonald, professor of Orthopaedic Surgery at Western University and London Health Sciences Centre in London, Ontario. He is one of the surgeons who helped design and develop the implant system.

“Knee replacement surgery has changed so much in recent years driven by the momentum of personalized medicine and an influx of innovative approaches,” Dr. MacDonald explained. “Whether achieved via the state-of-the-art new LANDMARK instrumentation system or in combination with the planning and balancing capabilities of the CORI KNEE Handheld Robotics Arthroplasty, the LANDMARK Knee provides us the flexibility to make patient-specific decisions while maintaining procedural efficiency. It is the perfect fit for surgeons looking to align with the principles of personalized care as the LANDMARK Knee was designed to meet the needs of surgeons and patients today and tomorrow.” 

Dr. Steven Haas, Chief of the Knee Service at Hospital for Special Surgery (HSS) in New York, was also a surgeon developer of the LANDMARK Knee. “The LANDMARK Knee was designed to address one of the biggest challenges in total knee arthroplasty, which is restoring anatomy without forcing unnecessary compromise,” Dr. Haas stated. “Its anatomic design helps accommodate the patient’s natural anatomy while supporting personalized alignment and patellofemoral function.”

The LANDMARK Knee will be commercially introduced through a phased launch focused on early customer adoption, with broader availability across markets expected throughout 2027. Smith+Nephew will unveil its new knee system to attendees during the American Association of Hip & Knee Surgeons (AAHKS) Annual Meeting in Dallas (Nov. 5-8).

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. Its 17,000 employees make a difference to patients’ lives through the company’s product portfolio, and the invention and application of new technologies across three global business units: Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management. Founded in Hull, U.K., in 1856, Smith+Nephew operates in roughly 100 countries, and generated $6.2 billion in 2025 sales. Smith+Nephew is a constituent of the FTSE100.

*Compared to conventional TKA designs

References
¹ Smith+Nephew 2026. Internal Report. CSD.REC.26.003_v1
² Smith + Nephew 2026. Internal Report. CSD.REC.26.004_v1
³ Smith+Nephew 2026. Internal Report. K24-PFET/CFET
⁴ Grieco TF, Sharma A, Dessinger GM, Cates HE, Komistek RD. In Vivo Kinematic Comparison of a Bicruciate Stabilized Total Knee Arthroplasty and the Normal Knee Using Fluoroscopy. J Arthroplasty. 2018;33(2):565-571.
⁵ Almaawi A, Hutt J, Masse V, Lavigne M, Vendittoli P. Impact of mechanical and restricted kinematic alignment on Knee anatomy in Total Knee Arthroplasty. J Arthroplasty. 2017;32(7):2133-2140.
⁶ MacDessi SJ, Griffith-Jones W, Harris IA, Bellemans J, Chen DB. Coronal Plane Alignment of the Knee (CPAK) classification. Bone Joint J. 2021;103-B(2):329-337. 7. Smith+Nephew 2026. Verification for Femur Implants
⁷ Fugit W, Lenz N. “Challenging Native Patella Positions Benefit with Flat Proximal Trochlea” The International Society for Technology in Arthroplasty, 37th Annual Congress, 2026, Munich, Germany, September
⁸ Fugit W, Lenz N. “The Benefits of a Kinematically Designed Femoral Implant Versus Symmetric Implants” The International Society for Technology in Arthroplasty, 37th Annual Congress, 2026, Munich, Germany, September