Cleared Traditional

DePuy Synthes VOLT? Proximal Tibia 3.5 Plating System

K260069 · Synthes GmbH · Orthopedic
Mar 2026
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K260069 is an FDA 510(k) clearance for the DePuy Synthes VOLT? Proximal Tibia 3.5 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 9, 2026, 59 days after receiving the submission on January 9, 2026. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K260069 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2026
Decision Date March 09, 2026
Days to Decision 59 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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