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Company has submitted a 510(k) application to the FDA for a solution dubbed the TESSA Spatial Surgery System.
March 4, 2025
By: Michael Barbella
Managing Editor
Smith+Nephew today is disclosing its efforts to develop arthroscopic surgical innovation in a new field—Spatial Surgery. The orthopedic device behemoth envisions this new frontier as an opportunity to provide personalized planning, augmented reality, and real-time data processing into platforms that interpret the surgical field intraoperatively.
Smith+Nephew has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for a technology called the TESSA◊ Spatial Surgery System. If cleared by the agency, TESSA (Tracking Enabled Spatial Surgery Assistant) would combine a real-time, tracking-enabled device powered by a NVIDIA GPU. By using video processing and augmented reality guidance, TESSA could assist surgeons in making anterior cruciate ligament reconstruction (ACLR) femoral tunnel decisions by navigating an operative plan.
TESSA is currently pending FDA clearance with proposed indications for use in anterior cruciate ligament surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. Technical error is the second most common reason for ACLR failure, with femoral (29%) and tibial (11%) tunnel malposition being the most predominant for ACLR failure.1 If cleared by the FDA, TESSA will aim to mitigate these technical failures through operative planning and intraoperative execution.
“We are excited to unveil our vision for Spatial Surgery—shaping the future of arthroscopic surgery by empowering healthcare professionals to utilize advanced technologies for patient personalization,” said Scott Schaffner, president of Global Sports Medicine at Smith+Nephew. “Challenging the status quo is what we do best, and we look forward to continuing the conversation and integrating Spatial Surgery as a core Sports Medicine discipline if cleared by the FDA.”
Smith+Nephew executives will be available next week at the American Academy of Orthopaedic Surgeons 2025 Annual Meeting to discuss the company’s foray into Spatial Surgery.
Smith+Nephew is a portfolio medical technology business focused on the soft and hard tissue repair, regeneration, and replacement. The company employs 17,000 workers, inventing and applying new technologies across three global business units: Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management.
Founded in Hull, United Kingdom, in 1856, Smith+Nephew now operates in about 100 countries, and generated $5.8 billion in 2024 sales. Smith+Nephew is a constituent of the FTSE100.
◊ Trademark of Smith+Nephew. Certain marks registered in the U.S. Patent and Trademark Office.
References1 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.
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