USFDAJul 29, 2026, 10:02 AM
Smith+Nephew gets FDA De Novo for TESSA Spatial Surgery System
AI Summary
Smith+Nephew announced that its TESSA Spatial Surgery System has received De Novo classification from the U.S. Food & Drug Administration (FDA). This system, leveraging AI and augmented reality, provides personalized planning and real-time tracking for arthroscopic procedures, initially targeting femoral anterior cruciate ligament reconstruction (ACLR) surgery. The classification establishes a new FDA category for intra-articular orthopedic stereotaxic navigation instruments, reinforcing Smith+Nephew's leadership in digital Sports Medicine. The TESSA System is scheduled for commercial introduction in Q3 2026.
Key Highlights
- FDA granted De Novo classification for Smith+Nephew's TESSA Spatial Surgery System.
- TESSA System utilizes AI and augmented reality for arthroscopic procedures.
- First indication for use is femoral anterior cruciate ligament reconstruction (ACLR) surgery.
- Aims to mitigate femoral malposition (29%) and tibial malposition (11%) in ACLR.
- Establishes a new FDA category for intra-articular orthopedic stereotaxic navigation instruments.
- Commercial introduction of the TESSA System is planned for Q3 2026.
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