Smith+Nephew said the U.S. Food and Drug Administration has granted De Novo classification to its TESSA Spatial Surgery System, a milestone the company describes as a major advance for sports medicine. The medical technology group said the platform is designed to support more personalized planning and new procedural approaches.
According to the announcement, the TESSA system uses accelerated computing to help bring a more advanced digital layer to surgical preparation and execution. The company is positioning the technology as part of a broader shift in how sports medicine procedures can be planned with greater individualization.
The FDA’s De Novo pathway is used for novel medical devices, making the decision important for Smith+Nephew as it prepares the product for market. The company said the commercial introduction of the TESSA Spatial Surgery System is scheduled for the third quarter of 2026, with an initial focus on early customer adoption.
Smith+Nephew added that deployment is expected to expand further in 2027. The clearance gives the company a regulatory foundation as it moves toward launch and seeks to establish the system in the sports medicine market.
