Cleared Traditional

K254093 - DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (FDA 510(k) Clearance)

K254093 · Synthes GmbH · Orthopedic device
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Mar 2026
Decision
81d
Days
-
Risk

K254093 is an FDA 510(k) clearance for the DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System.

Submitted by Synthes GmbH (Zuchwil, CH). The FDA issued a Cleared decision on March 10, 2026 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K254093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date March 10, 2026
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -