Cleared Traditional

K260115 - DRIM-Nail System

K260115 · 41Medical AG · Orthopedic device
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Sep 2026
Decision
240d
Days
-
Risk

K260115 is an FDA 510(k) clearance for the DRIM-Nail System.

Submitted by 41Medical AG (Bettlach, CH). The FDA issued a Cleared decision on September 11, 2026 after a review of 240 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K260115

510(k) Number K260115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2026
Decision Date September 11, 2026
Days to Decision 240 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 122d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -