Decoding Smith+Nephew’s Outpatient Robotics Play With the LANDMARK Knee

NEW YORK, NY – September 22, 2026 – The business of joint replacement is undergoing a profound geographic shift. As procedures migrate rapidly from traditional hospital operating rooms to ambulatory surgery centers (ASCs), the medical technology giants supplying these procedures are locked in an arms race to adapt. Today’s announcement from British medtech heavyweight Smith+Nephew regarding the U.S. Food and Drug Administration (FDA) 510(k) clearance of its LANDMARK Total Knee System is far more than a routine regulatory nod. It is a calculated, strategic strike aimed directly at the vulnerabilities of its largest competitors in the booming outpatient market.

The global medical technology company, which generated $6.2 billion in annual sales in 2025, confirmed that the first surgical cases utilizing the LANDMARK system were completed this week in London, Ontario. Designed to integrate natively with the company’s CORI Handheld Robotics platform, the next-generation implant targets a persistent challenge in orthopaedics: personalizing knee kinematics without overwhelming the physical and financial constraints of outpatient facilities.

Engineering for the Ambulatory Surgery Center Boom

To understand the business momentum behind this launch, one must look at the shifting economics of orthopaedic surgery. Procedures in U.S. ASCs are expanding at a compound annual growth rate exceeding 10 percent, propelled by favorable reimbursement changes from the Centers for Medicare & Medicaid Services (CMS) and aggressive commercial payor preferences for lower-cost surgical settings.

However, the robotic systems that have become the standard of care for total knee arthroplasty (TKA) were originally designed for sprawling hospital infrastructure. Market-leading systems, such as Stryker’s Mako SmartRobotics, command a massive physical footprint, weighing upwards of 700 pounds, and require substantial capital investments often exceeding $1 million. Furthermore, they rely on pre-operative CT scans, which create logistical friction, scheduling bottlenecks, and added imaging costs for independent surgery centers.

Smith+Nephew is weaponizing these constraints. The newly cleared LANDMARK system is optimized specifically for the company's CORI robotics platform, which features a highly compact, mobile console and operates entirely image-free, utilizing intraoperative point mapping instead of pre-operative CT scans.

Beyond the robot itself, the commercial battleground is being fought on "tray economics." Traditional knee systems require six to nine heavy instrument trays per case, driving up sterilization overhead, storage requirements, and operating room turnover times. The new implant system has been engineered to reduce this burden dramatically, targeting a streamlined two to four trays. According to one independent healthcare administrator analyzing the launch, this reduction in tray burden is often the deciding factor for ASC procurement committees operating on razor-thin margins and tight turnaround schedules. This strategy is already bearing fruit; during its 2025 earnings cycle, the British device maker revealed that 40 percent of all its robotic installations were placed directly into ASCs.

Biomechanics and the Quest for the "Forgotten Knee"

While operational efficiency drives facility adoption, clinical differentiation remains the primary currency for surgeons. Historically, 15 to 20 percent of total knee replacement patients report lingering dissatisfaction, often experiencing anterior knee pain or a feeling that the joint is unnatural—a hurdle the industry refers to as the quest for the "forgotten knee."

Standard mechanical alignment forces patients into a rigid, systematic anatomical profile that can alter normal soft-tissue tension. The LANDMARK system leans heavily into the momentum of Personalized Alignment, or restricted Kinematic Alignment. It features variable lateral-medial condylar radii derived from asymmetric anatomy to match native femoral roll-back during deep flexion. Crucially, the design incorporates a smooth, flattened anterior trochlear groove entry point. This geometry is specifically engineered to eliminate patellofemoral overstuffing and optimize natural tracking without requiring invasive soft-tissue releases.

Dr. Steven Haas, Chief of the Knee Service at the Hospital for Special Surgery in New York and a co-developer of the system, highlighted this clinical pivot. "The LANDMARK Knee was designed to address one of the biggest challenges in total knee arthroplasty, which is restoring anatomy without forcing unnecessary compromise," he noted. "Its anatomic design helps accommodate the patient's natural anatomy while supporting personalized alignment and patellofemoral function.”

Underpinning this anatomic design is the company’s proprietary CONCELOC Technology. The femoral component is fully 3D-printed using Direct Metal Laser Sintering to create a highly porous titanium structure. With a mean porosity of 70 to 80 percent, this trabecular architecture mimics human cancellous bone, optimizing early biological bone-cell colonization while reducing the stress-shielding typically associated with solid metal implants.

A Catalyst for Corporate Turnaround

From a corporate momentum perspective, this clearance is a critical milestone in Smith+Nephew’s ongoing "RISE" turnaround strategy. Under the leadership of CEO Deepak Nath and Orthopaedics President Nate Folkert, the company has been aggressively working to reclaim market share in the highly contested North American reconstructive market, where knee implants represent a pivotal, high-margin segment.

"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,” Folkert stated following the FDA clearance. “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 turnaround narrative is showing signs of traction. The company's orthopaedics underlying revenue growth rebounded to 5.1 percent in 2025, pushing overall trading margins near 20 percent. However, to sustain this trajectory against rivals like Zimmer Biomet and Johnson & Johnson’s DePuy Synthes, the company requires a flagship implant that pulls through its robotics utilization and secures long-term implant contracts.

The Battle for Market Share

Execution of the commercial rollout will be the ultimate test of this growth signal. The company has initiated a phased launch focused initially on early customer adoption and centers of excellence. The system will make its formal debut to the broader surgical community at the American Association of Hip & Knee Surgeons (AAHKS) Annual Meeting in Dallas this November.

Surgeons transitioning to the new ecosystem will face a learning curve. Unlike traditional resection jigs or robotic arms that utilize oscillating saws, the CORI system relies on a handheld high-speed robotic burr. Clinical developers indicate this requires an adjustment period of approximately 10 to 15 cases. However, proponents argue that the robotic milling technique ultimately provides superior precision, avoiding the saw-blade deflection that can occur in hard, sclerotic bone.

Dr. Steven MacDonald, Professor of Orthopaedic Surgery at Western University and the surgeon who completed the inaugural cases, emphasized this balance of precision and adaptability. “Knee replacement surgery has changed so much in recent years driven by the momentum of personalized medicine and an influx of innovative approaches,” he 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.”

As the company prepares for broader market availability and the introduction of a cemented variant in 2027, the industry will be watching closely to see if this combination of 3D-printed anatomic design and outpatient-friendly robotics can successfully disrupt the established hierarchy of orthopaedic reconstruction.