FDA 510(k)

DePuy Synthes VOLT Proximal Tibia 3.5 Plating System

K-Number: K260069 · 2026-03-09

Decision Date2026-03-09

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DePuy Synthes VOLT Proximal Tibia 3.5 Plating System is a medical device manufactured by Synthes GmbH. It received FDA 510(k) clearance on 2026-03-09 under approval number K260069. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes VOLT Proximal Tibia 3.5 Plating System?

DePuy Synthes VOLT Proximal Tibia 3.5 Plating System is a medical device that received FDA 510(k) clearance on 2026-03-09. It is manufactured by Synthes GmbH. The 510(k) number is K260069.

When was DePuy Synthes VOLT Proximal Tibia 3.5 Plating System approved by the FDA?

DePuy Synthes VOLT Proximal Tibia 3.5 Plating System received FDA 510(k) clearance on 2026-03-09, under approval number K260069.

What company makes DePuy Synthes VOLT Proximal Tibia 3.5 Plating System?

DePuy Synthes VOLT Proximal Tibia 3.5 Plating System is manufactured by Synthes GmbH.

What is the FDA product code for DePuy Synthes VOLT Proximal Tibia 3.5 Plating System?

The FDA product code for DePuy Synthes VOLT Proximal Tibia 3.5 Plating System is HRS.

Related Clinical Trials

NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT07102160 Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking RECRUITING NCT07355270 A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study) RECRUITING NCT07134257 Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures RECRUITING

Other Devices by Synthes GmbH

K233994VOLT Proximal Humerus 3.5 Plating System K233967DePuy Synthes MatrixSTERNUM Fixation System K243715Synthes Patient Specific Implants K241927Synthes Graphic Case & Tray System K254093DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System K254054VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System

View all 7 devices →

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.