LONDON, United Kingdom, July 29, 2026
Smith+Nephew has achieved a significant regulatory milestone after receiving U.S. Food and Drug Administration (FDA) De Novo classification for its TESSA™ (Tracking Enabled Spatial Surgery Assistant) Spatial Surgery System, introducing a new category of AI-powered orthopedic navigation technology for sports medicine. The innovative platform combines artificial intelligence (AI), augmented reality (AR), advanced imaging, real-time navigation, and patient-specific 3D anatomical modeling to enhance the accuracy of arthroscopic knee surgery, beginning with anterior cruciate ligament reconstruction (ACLR). The FDA’s De Novo classification establishes TESSA™ as the first intra-articular orthopedic stereotaxic navigation system, creating a regulatory pathway for future innovations in digital orthopedic surgery. Scheduled for commercial launch during the third quarter of 2026, the technology represents a major advancement in personalized orthopedic care, helping surgeons improve procedural precision while supporting better patient outcomes through intelligent, image-guided surgical planning.
FDA De Novo Classification Introduces a New Era of Digital Orthopedic Surgery
The FDA De Novo classification recognizes the TESSA Spatial Surgery System as the first device within a newly established category of intra-articular orthopedic stereotaxic navigation instruments, highlighting its innovative role in modern orthopedic surgery. The platform integrates preoperative MRI or CT imaging with cloud-based deep-learning algorithms, generating highly detailed patient-specific three-dimensional anatomical models before surgery. Powered by AI-enabled computing infrastructure, the system overlays these personalized anatomical reconstructions directly onto live 4K arthroscopic video, providing surgeons with real-time augmented reality navigation throughout the procedure. This advanced visualization technology enables greater surgical precision while preserving surgeon control, supporting more informed intraoperative decision-making rather than replacing clinical expertise. By combining digital planning with real-time navigation, Smith+Nephew is advancing the next generation of intelligent, personalized surgical technology.
AI-Powered Navigation Improves ACL Reconstruction Precision
The first approved clinical application for the TESSA™ Spatial Surgery System focuses on femoral anterior cruciate ligament reconstruction (ACLR), one of the most frequently performed sports medicine procedures worldwide. Improper placement of the femoral and tibial tunnels remains one of the leading causes of ACL reconstruction failure, often resulting in revision surgery and prolonged patient recovery. The TESSA platform addresses this challenge by providing surgeons with AI-guided spatial navigation, allowing accurate visualization of patient-specific anatomy during tunnel placement and surgical instrument positioning. Developed using technology originally created by Perceive3D, now part of Smith+Nephew, the platform combines machine learning, advanced imaging, and augmented reality to deliver enhanced procedural guidance. The technology is expected to improve consistency, reduce technical variability, and support more personalized surgical approaches for patients undergoing minimally invasive arthroscopic knee reconstruction.
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Digital Innovation Expands the Future of Sports Medicine
The FDA clearance positions Smith+Nephew at the forefront of digital orthopedic innovation, reinforcing the growing importance of artificial intelligence, augmented reality, and data-driven surgical navigation in modern healthcare. Following its commercial introduction in Q3 2026, the company plans broader deployment throughout 2027, initially targeting early adopters before expanding to additional orthopedic centers. Although the first indication focuses on ACL reconstruction, Smith+Nephew anticipates extending the TESSA™ platform across a wider range of arthroscopic procedures, creating new opportunities for personalized treatment planning and precision-guided surgery. As healthcare increasingly embraces intelligent technologies to improve procedural accuracy, patient safety, and surgical efficiency, the TESSA Spatial Surgery System represents a significant step toward transforming sports medicine through next-generation AI-assisted orthopedic navigation and advanced digital surgery solutions.
Source: Smith+Nephew press release
