Natural design. Amplified: Smith+Nephew announces FDA 510(k) clearance and first surgical cases of LANDMARK Total Knee System

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and has completed the first surgical cases with LANDMARK Total Knee System, a next-generation knee replacement solution designed to replicate healthy knee anatomy and the knees natural motion and support a more personalized approach to total knee arthroplasty.

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

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 utilizing CONCELOC Technology³

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, said Nate Folkert, President, Smith+Nephew Orthopaedics. Together, the natural design of LANDMARK Knee paired with CORI KNEE Handheld Robotics Arthroplasty provides a powerful solution to address the evolving needs of orthopaedic surgery.”

The first LANDMARK Knee surgical cases were completed this week by Dr. Steven MacDonald, Professor of Orthopaedic Surgery, Western University and London Health Sciences Centre in London, Ontario, who is one of the surgeons who helped with the design and development of this innovative 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, explained Dr. MacDonald. 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 for 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 said. “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 be unveiling its new knee system to HCP attendees during the American Association of Hip & Knee Surgeons (AAHKS) Annual Meeting in Dallas November 5-8. Stop by booth number 621 to see the new LANDMARK Knee in action.

To learn more, visit our LANDMARK Knee web page.

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Media Inquiries

Gina Kamler
+1 (901) 262-9070
gina.kamler@smith-nephew.com

*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

About Smith+Nephew
Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore peoples bodies and their self-belief by using technology to take the limits off living. We call this purpose Life Unlimited. Our 17,000 employees deliver this mission every day, making a difference to patients lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.

Founded in Hull, UK, in 1856, we now operate in around 100 countries, and generated annual sales of $6.2 billion in 2025. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms Group and Smith+Nephew are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on X, LinkedIn, Instagram or Facebook.

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