Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has been granted De Novo classification by the U.S. Food & Drug Administration (FDA) for its TESSA Spatial Surgery System. Utilizing cutting-edge accelerated computing and AI technology, the TESSA (Tracking Enabled Spatial Surgery Assistant) System brings personalized planning, augmented reality, advanced imaging, navigation, and real-time tracking to help transform arthroscopic procedures, leveraging technology originally developed by Perceive3D S.A., a spin-off from the University of Coimbra that became part of Smith+Nephew through acquisition.

The TESSA System 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 first indication for use for the TESSA System is femoral anterior cruciate ligament reconstruction (ACLR) surgery of the knee, where femoral malposition (29%) and tibial malposition (11%) are among the most common reasons for ACLR failure.2 The TESSA System will assist a surgeon in placement and navigation of the femoral tunnel – helping mitigate these challenges using augmented reality technology.

“Musculoskeletal innovation is entering a new era, where enabling technologies matter just as much as implants,” said Dr. Jorge Chahla, 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.”

With De Novo classification, the TESSA System serves as the first device in a new FDA category for intra-articular orthopedic stereotaxic navigation instruments - establishing a regulatory reference point for future innovations and reinforcing Smith+Nephew's leadership in personalized, data-enabled, digital Sports Medicine.

”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,” said Scott Schaffner, President of Global Sports Medicine at Smith+Nephew. “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.”

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

The TESSA Spatial Surgery System will be commercially introduced during Q3 2026 focusing on early customer adoption and will see increased deployment in 2027. Anyone wishing to learn more about Smith+Nephew’s category defining spatial surgery solutions for Sports Medicine are encouraged to visit: https://spatialsurgery.com.

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* 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.

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 people’s 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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