Not Cleared Direct

DEN250037 - TESSA Spatial Surgery System

Also marketed or referenced as:
INTELLIO Tablet (72205455)
DEN250037 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
318d
Days
-
Risk

DEN250037 is an FDA 510(k) submission (not cleared) for the TESSA Spatial Surgery System.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Not Cleared (DENG) decision on July 6, 2026 after a review of 318 days.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 318 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number DEN250037 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 22, 2025
Decision Date July 06, 2026
Days to Decision 318 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 122d · This submission: 318d
Pathway characteristics

Device Classification

Product Code SIQ
Device Class -