Smith and Nephew TESSA Spatial Surgery System granted FDA De Novo classification
By Azmed Devices Editorial Team
Smith and Nephew has received FDA De Novo classification for its new TESSA Spatial Surgery System, which utilizes AI and augmented reality to enhance precision in arthroscopic procedures, beginning with ACL reconstruction.
Smith and Nephew recently announced that the U.S. Food and Drug Administration has granted De Novo classification to its TESSA Spatial Surgery System. This new technology utilizes advanced computing and artificial intelligence to offer personalized planning, real-time tracking, and augmented reality during arthroscopic surgeries. According to the company, the system was developed using technology acquired from Perceive3D S.A. The platform is designed to assist surgeons with enhanced imaging and navigation, representing a significant advancement in the company's digital sports medicine portfolio.
The TESSA System integrates preoperative imaging, such as MR or CT scans, with cloud-based deep-learning algorithms powered by Amazon Web Services and NVIDIA infrastructure. This combination generates precise 3D anatomical models that are overlaid onto live 4K arthroscopic video. By providing real-time, video-based navigation, the system aims to improve surgical accuracy. The company reported that this technology is intended to support surgeon execution and planning rather than replace clinical judgment during complex medical procedures.
The initial application for the TESSA System is focused on femoral anterior cruciate ligament reconstruction. Smith and Nephew noted that femoral and tibial malposition are significant factors in surgical failure, with cited rates of 29 percent and 11 percent, respectively. The system provides guidance for femoral tunnel placement and trajectory to mitigate these technical challenges. Experts in the field have highlighted the system's potential to solve unmet needs in orthopedic surgery by addressing common errors associated with traditional manual techniques.
As the first device in this new FDA category for intra-articular orthopedic stereotaxic navigation, the TESSA System serves as a regulatory benchmark for future innovation. Smith and Nephew plans to introduce the product commercially in the third quarter of 2026, with an emphasis on early customer adoption followed by a broader deployment in 2027. The company anticipates that the technology will eventually expand to support a wide spectrum of arthroscopic procedures, further establishing its leadership in the sports medicine market.
Source
This article summarizes an official Smith & Nephew announcement. Read the original press release at https://www.smith-nephew.com/en/news/2026/07/29/tessa-spatial-surgery-system-granted-de-novo-classification-by-the-fda. Product availability in Azerbaijan is subject to local registration; contact Azmed Devices for current status.
