Cleared Traditional

DePuy Synthes VOLT? Medial Distal Femur 3.5 Plating System

K254093 · Synthes GmbH · Orthopedic

Mar 2026

Decision

81d

Days

—

Risk

About This 510(k) Submission

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, 81 days after receiving the submission on December 19, 2025. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number	K254093 FDA.gov
FDA Decision	Cleared 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