Smith+Nephew TESSA Surgery System Obtains FDA De Novo Classification

Smith+Nephew has been granted De Novo classification by the U.S. Food & Drug Administration (FDA) for its TESSA Spatial Surgery System. The platform utilizes accelerated computing and artificial intelligence to integrate personalized surgical planning, augmented reality, advanced imaging, navigation, and real-time tracking into arthroscopic procedures.

System Architecture and AI Infrastructure
The TESSA (Tracking Enabled Spatial Surgery Assistant) System leverages technology originally developed by Perceive3D S.A., a University of Coimbra spin-off acquired by Smith+Nephew. The system processes preoperative magnetic resonance (MR) or computed tomography (CT) scans using cloud-based deep-learning neural network algorithms hosted on Amazon Web Services (AWS) to generate patient-specific 3D anatomical models.

Powered by NVIDIA AI infrastructure, the TESSA System overlays these patient-specific 3D bone models directly onto live 4K arthroscopic video feeds. This video-based navigation feed is designed to assist surgeons in visualizing joint anatomy with increased accuracy during operative procedures.

Clinical Indications and Surgical Navigation
The primary indication for the TESSA System is femoral anterior cruciate ligament reconstruction (ACLR) surgery of the knee. Clinical data indicates that femoral malposition (29%) and tibial malposition (11%) represent primary causes of ACLR failure. The TESSA System assists surgeons in the positioning and navigation of the femoral tunnel, using augmented reality technology to address these alignment challenges.

Regulatory Classification and Portfolio Expansion
With the De Novo classification, the TESSA System establishes a new FDA regulatory category for intra-articular orthopedic stereotaxic navigation instruments. The classification creates a regulatory reference framework for intra-articular navigation tools and expands Smith+Nephew's digital sports medicine product portfolio.

Edited by Romila DSilva, Induportals Editor, with AI assistance.