Not Cleared Direct

DEN250067 - ReneuRx™ (Neural Ice)

DEN250067 · Brixton Biosciences · Orthopedic device
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Aug 2026
Decision
249d
Days
-
Risk

DEN250067 is an FDA 510(k) submission (not cleared) for the ReneuRx™ (Neural Ice).

Submitted by Brixton Biosciences (Cambridge, US). The FDA issued a Not Cleared (DENG) decision on August 21, 2026 after a review of 249 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Orthopedic review framework.

FDA 510(k) Submission Details - DEN250067

510(k) Number DEN250067 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 15, 2025
Decision Date August 21, 2026
Days to Decision 249 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 122d · This submission: 249d
Pathway characteristics

SJA Device Classification - Class ,

Product Code SJA
Device Class -
DEN250067 · ReneuRx™ (Neural Ice)
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