FDA Grants De Novo Classification to Smith+Nephew’s TESSA Spatial Surgery System

Smith+Nephew has received U.S. Food and Drug Administration (FDA) De Novo classification for its TESSA (Tracking Enabled Spatial Surgery Assistant) Spatial Surgery System. Using cutting-edge accelerated computing and AI technology, the TESSA System brings personalized planning, augmented reality, advanced imaging, navigation, and real-time tracking to help transform arthroscopic procedures, according to the company.

The TESSA System leverages technology originally developed by Perceive3D S.A., a spin-off from the University of Coimbra that became part of Smith+Nephew through acquisition. The new product uses preoperative MR or CT scans with cloud-based deep-learning neural net algorithms running on Amazon Web Services (AWS) to generate patient-specific 3D anatomical models. Powered by NVIDIA AI infrastructure, the TESSA System overlays this patient-specific 3D bone model onto live 4K arthroscopic video, providing real-time video-based navigation to help surgeons visualize anatomy with greater accuracy during surgery.*¹

The De Novo classification permits the TESSA System to be used in femoral anterior cruciate ligament reconstruction (ACLR) knee surgery, where femoral malposition (29%) and tibial malposition (11%) are among the most common reasons for failure.² The TESSA System mitigates these challenges by assisting a surgeon in placement and navigating the femoral tunnel through augmented reality technology.

”The TESSA Spatial Surgery System is going to change the game for sports medicine surgeons—bringing procedural innovation and patient personalization to an entirely new level,” Smith+Nephew Global Sports Medicine President Scott Schaffner said. “Over time, we anticipate the TESSA System will support applications across a broad spectrum of arthroscopic procedures, starting with ACL reconstruction, where tunnel placement and trajectory remain significant clinical challenges.”

With De Novo classification, the TESSA System is the first device in a new FDA category for intra-articular orthopedic stereotaxic navigation instruments. The milestone sets a regulatory reference point for future innovations and reinforces Smith+Nephew’s leadership in personalized, data-enabled, digital sports medicine, company executives claim.

“Musculoskeletal innovation is entering a new era, where enabling technologies matter just as much as implants,” stated Dr. Jorge Chahla, an orthopedic surgeon and assistant professor of Orthopedic Surgery at Rush University Medical Center. “Starting with ACL reconstruction, spatial surgery technology is designed to support surgeon planning and execution, not to replace clinical decision-making.”

The TESSA Spatial Surgery System is being commercially introduced this quarter, with an initial focus on early customer adoption; an increased rollout will transpire next year.

“The TESSA System is modernizing ACL surgery by solving an unmet need,” commented Dr. Anil Ranawat, chief of the Hip and Knee Division of Sports Medicine at Hospital for Special Surgery in New York, N.Y. “It uses computer mapping to help give us accurate tunnel placement—a major problem with current ACL surgery solutions.”

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 invention and application of new technologies across three global business units: Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management. Founded in Hull, United Kingdom, in 1856, Smith+Nephew currently operates in around 100 countries, and generated $6.2 billion in 2025 sales. Smith+Nephew is a constituent of the FTSE100.

* Comparison to published data on standard ACL reconstruction techniques

References
¹ Smith+Nephew. 2025. Internal Report. 10153865
² Li X, Yan L, Li D, et al. Failure modes after anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Int Orthop. 2023;47(3):719–734.