Smith+Nephew (LSE:SN, NYSE:SNN) has received De Novo classification from the U.S. This achievement marks a significant step in the evolution of Sports Medicine, as the technology is set to redefine personalized surgical planning and procedural innovation. The system combines AI and real-time navigation to enhance accuracy during arthroscopic surgeries, positioning Smith+Nephew as a leader in digital transformation within the medical field.
At the core of the TESSA System is the integration of cutting-edge accelerated computing and artificial intelligence. This technology enables real-time navigation and augmented reality features during complex procedures. The system builds on tools initially developed by Perceive3D S.A., a spin-off from the University of Coimbra that was acquired by Smith+Nephew, showcasing the company’s focus on leveraging innovation for surgical advancement.
The system operates by processing preoperative MRI or CT scans to generate detailed 3D anatomical models. These models are created using cloud-based deep-learning algorithms powered by Amazon Web Services (AWS). NVIDIA AI infrastructure further enhances the system by overlaying the 3D model onto live 4K arthroscopic video, providing surgeons with real-time navigation and a clearer view of anatomical structures during surgery.
TESSA Targets ACL Surgery Challenges
The first approved application of the TESSA System is for anterior cruciate ligament reconstruction (ACLR) of the knee. ACL malposition is a known contributor to surgical failure, with femoral malposition occurring in 29% of cases and tibial malposition in 11%. TESSA aims to reduce these errors by improving visualization and accuracy in femoral tunnel placement, a critical component of successful ACL surgery.
Dr. Jorge Chahla, an Orthopedic Surgeon and Assistant Professor of Orthopedic Surgery at Rush University Medical Center, highlighted the role of technology in modern musculoskeletal innovation. He noted that systems like TESSA are designed to support surgeons in their planning and execution, while emphasizing that clinical judgment remains central to surgical success.
Scott Schaffner, President of Global Sports Medicine at Smith+Nephew, outlined the long-term vision for TESSA. While the system initially focuses on ACL reconstruction, he anticipates its use will expand to a range of arthroscopic procedures over time. The technology is designed to address persistent challenges in tunnel placement and trajectory, making it a valuable tool in the surgical toolkit.
The FDA’s De Novo classification for the TESSA System marks its entry into a new regulatory category for intra-articular orthopedic stereotaxic navigation instruments. This milestone not only validates the system’s innovation but also sets a foundation for future advancements in the field. The classification reinforces Smith+Nephew’s leadership in personalized, data-driven surgical solutions.
Dr. Anil Ranawat, Chief of the Hip and Knee Division of Sports Medicine at Hospital for Special Surgery in New York, praised the system for addressing a critical issue in ACL surgery. He highlighted how TESSA uses computer mapping to assist with tunnel placement, offering a meaningful improvement over existing methods and enhancing outcomes for patients.
Smith+Nephew plans to commercially introduce the TESSA Spatial Surgery System in the third quarter of 2026, with a focus on early adopters in the medical community. The company expects full-scale deployment by 2027, allowing a broader adoption of the system as surgeons become more familiar with its capabilities. Those interested in learning more about TESSA can visit the official website, spatialsurgery.com, for detailed information.
The CEO and leadership team at Smith+Nephew are committed to advancing digital transformation in orthopedics. By integrating AI and cloud-based tools into surgical workflows, the company aims to deliver greater precision and personalization to patients, continuing its mission to improve outcomes and redefine the future of medical care.