Smith+Nephew Receives FDA De Novo Classification for the TESSA◊ Spatial Surgery System
Smith+Nephew has announced that 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.
* Comparison to published data on standard ACL reconstruction techniques
◊ Trademark of Smith+Nephew. Certain marks registered in US Patent and Trademark Office.
- Smith+Nephew. 2025. Internal Report. 10153865
- 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.
Source: Smith+Nephew