FDA Grants De Novo to Smith+Nephew's TESSA Navigation System for ACL Surgery

The US Food and Drug Administration has granted De Novo classification to Smith+Nephew's TESSA Spatial Surgery System, a navigation system that overlays a patient-specific 3D bone model on live arthroscopic video to guide femoral tunnel placement in anterior cruciate ligament (ACL) reconstruction, the company announced on July 29.

The FDA's decision letter, dated July 6 and addressed to Smith & Nephew, Inc., of Andover, Massachusetts, covers the TESSA Spatial Surgery System and the company's INTELLIO Tablet. It places them in Class II under a new regulation, 21 CFR 888.4561, with the generic name "intra-articular orthopedic stereotaxic navigation instrument." The FDA's De Novo database lists the request as DEN250037, received August 22, 2025, with product code SIQ and review by the orthopedic panel.

What the FDA authorized

According to the letter, TESSA is indicated for primary ACL reconstruction in patients aged 18 and older in whom stereotactic planning and navigation guidance of femoral tunnel placement may be appropriate and where rigid bony landmarks can be identified. The INTELLIO Tablet is intended for wired or wireless remote control of compatible Smith+Nephew devices in the operating room, including cameras, resection and fluid management systems and the TESSA navigation system.

The FDA defines the new device type as a rigid frame of reference with a calibrated guide mechanism and fiducial markers temporarily attached to structures inside the joint, with the markers continuously tracked to position instruments. The order also classifies substantially equivalent devices of this generic type into Class II.

How the company describes the system

Smith+Nephew said TESSA, short for Tracking Enabled Spatial Surgery Assistant, uses preoperative MR or CT scans processed by cloud-based deep-learning algorithms running on Amazon Web Services to build a 3D model of the patient's anatomy. Running on NVIDIA AI infrastructure, the system overlays that model on live 4K arthroscopic video for real-time navigation, the company said. The technology was originally developed by Perceive3D, a University of Coimbra spin-off that Smith+Nephew acquired.

The company cited a published review finding that femoral malposition (29%) and tibial malposition (11%) are among the most common reasons ACL reconstructions fail. Its claim of improved visualization accuracy rests on an internal report compared with published data on standard techniques, according to the release.

"Starting with ACL reconstruction, spatial surgery technology is designed to support surgeon planning and execution, not to replace clinical decision making," said Jorge Chahla, an orthopedic surgeon at Rush University Medical Center, in the company's release.

Smith+Nephew said the system will be introduced commercially in the third quarter of 2026, focusing on early customer adoption, with increased deployment in 2027. The company said it expects to extend TESSA to other arthroscopic procedures over time. Pricing was not disclosed.