Cleared Traditional

VOLT? Ankle Trauma 2.7/3.5 Plating System; VOLT? Calcaneus 2.7 Plating System

K254054 · Synthes GmbH · Orthopedic
Mar 2026
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K254054 is an FDA 510(k) clearance for the VOLT? Ankle Trauma 2.7/3.5 Plating System; VOLT? Calcaneus 2.7 Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Synthes GmbH (Zuchwil, CH). The FDA issued a Cleared decision on March 2, 2026, 75 days after receiving the submission on December 17, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K254054 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2025
Decision Date March 02, 2026
Days to Decision 75 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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