VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System— 510(k) K254054

Substantially Equivalent

Synthes GmbH

FDA 510(k) clearance K254054 for VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System, Substantially Equivalent on 2026-03-02. Applicant: Synthes GmbH.

Clearance details

Applicant: Synthes GmbH
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2025-12-17
Decision date: 2026-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zuchwil, CH

Download summary PDF View on FDA.gov ↗

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.