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Wire · regulatory

Smith+Nephew's TESSA™ Spatial Surgery System granted De Novo classification by the ...

31 July 2026 · By · Wire by Fusion42

Published

31 July 2026

Topic

regulatory

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at orthospinenews.com →

◆ Verified

Fusion42 · 31 July 2026 · Fusion42 review

Smith+Nephew has received FDA De Novo classification for its TESSA Spatial Surgery System, a new platform that uses AI and augmented reality to provide real-time, 3D surgical guidance. This approval establishes a new device category for intra-articular orthopedic stereotaxic navigation instruments, with the first application being ACL reconstruction surgery.

This Wire brief sits within Fusion42's coverage of Medtech.

◆ ◆ The Wire takeaway

A new regulatory pathway for surgical AR is now open, with an established benchmark for performance and safety. Your previously novel device now has a defined category and a major competitor's product to beat.

◆ Coverage

1 source · 31 Jul 2026

◆ Related on Wire

◆ Topics

Medtechfda-approvalmedtechsurgical-arai-in-healthcaresports-medicine