DePuy Synthes VOLT Proximal Tibia 3.5 Plating System— 510(k) K260069

Name: FDA 510(k) clearance K260069
Creator: U.S. Food and Drug Administration
Published: 2026-03-09

Substantially Equivalent

Synthes GmbH

FDA 510(k) clearance K260069 for DePuy Synthes VOLT Proximal Tibia 3.5 Plating System, Substantially Equivalent on 2026-03-09. Applicant: Synthes GmbH. Device class: 2.

Summary

Synthes GmbH's DePuy Synthes VOLT Proximal Tibia 3.5 Plating System is filed under HRS, bone fixation plates. The record doesn't list plate lengths or components.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Synthes filed from Zuchwil, Switzerland. Review took 59 calendar days (January 9 to March 9, 2026).

Clearance details

Applicant: Synthes GmbH
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-01-09
Decision date: 2026-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zuchwil, CH

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.