Smith+Nephew Wins FDA Clearance for TESSA Surgery System
Smith+Nephew has received de novo clearance from the US Food and Drug Administration for its TESSA spatial surgery system, the company said.
TESSA stands for Tracking-Enabled Spatial Surgery Assistant. Smith+Nephew said the platform uses accelerated computing and artificial intelligence to support personalised planning, augmented reality, state-of-the-art imaging, navigation and live tracking. The company said the system is intended to help advance arthroscopic procedures by bringing more digital capability into the surgical field.
The London-based company submitted TESSA to the FDA last year. It described spatial surgery as a way to combine personalised planning, augmented reality and live data processing in systems that interpret the surgical field during an operation. Smith+Nephew said the technology came out of Perceive3D, a spin-off from the University of Coimbra that it later acquired.
The system uses pre-operative MR or CT scans together with cloud-based deep-learning neural network algorithms running on Amazon Web Services. Nvidia AI infrastructure also powers the platform. Smith+Nephew said TESSA overlays a patient-specific 3D bone model on live 4K arthroscopic video. The company said this provides real-time video-based navigation designed to help surgeons visualise anatomy with greater accuracy during surgery.
The first indication for use covers femoral anterior cruciate ligament reconstruction surgery of the knee. In that setting, TESSA can assist a surgeon with placement and navigation of the femoral tunnel by using augmented reality technology.
Smith+Nephew said the de novo classification makes TESSA the first device in a new FDA category for intra-articular orthopaedic stereotaxic navigation instruments. The company said it plans to commercialise the system in the third quarter, with an initial focus on early customer adoption. It then expects to expand deployment in 2027.
Scott Schaffner, president of global sports medicine at Smith+Nephew, said the TESSA Spatial Surgery System is intended to bring procedural innovation and patient personalisation to sports medicine surgeons at a new level. He said the system is expected, over time, to support applications across a wide range of arthroscopic procedures, starting with ACL reconstruction, where tunnel placement and trajectory remain major clinical challenges.
Dr Anil Ranawat, chief of the hip and knee division of sports medicine at Hospital for Special Surgery in New York, said the system is modernising ACL surgery by fulfilling an unmet need. He said computer mapping helps provide accurate tunnel placement, which continues as a major problem in current ACL surgery solutions.
Dr Jorge Chahla, an orthopaedic surgeon and assistant professor of orthopaedic surgery at Rush University Medical Centre, said musculoskeletal innovation is entering a new stage in which enabling technologies matter as much as implants. He said that, starting with ACL reconstruction, spatial surgery technology is designed to support surgeon planning and execution, not to replace clinical decision-making.
Smith+Nephew said the platform brings together imaging, navigation and tracking in a single system for intraoperative use. The company positioned TESSA as part of its wider effort to introduce digital applications into orthopaedic surgery, with ACL reconstruction as the initial clinical focus.
The de novo clearance gives TESSA a defined regulatory route in the United States and establishes the system within a new device category. Smith+Nephew said the approval indicates the start of its commercial rollout, with the platform due to be introduced first to early customers before wider deployment follows.
