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FDA 510(k)

Arthrex Variable Angle (VA) Proximal Tibia Plating System

K-Number: K253713 · 2026-01-21

ApplicantArthrex, Inc.
Decision Date2026-01-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Variable Angle (VA) Proximal Tibia Plating System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2026-01-21 under approval number K253713. 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 Arthrex Variable Angle (VA) Proximal Tibia Plating System?

Arthrex Variable Angle (VA) Proximal Tibia Plating System is a medical device that received FDA 510(k) clearance on 2026-01-21. It is manufactured by Arthrex, Inc.. The 510(k) number is K253713.

When was Arthrex Variable Angle (VA) Proximal Tibia Plating System approved by the FDA?

Arthrex Variable Angle (VA) Proximal Tibia Plating System received FDA 510(k) clearance on 2026-01-21, under approval number K253713.

What company makes Arthrex Variable Angle (VA) Proximal Tibia Plating System?

Arthrex Variable Angle (VA) Proximal Tibia Plating System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Variable Angle (VA) Proximal Tibia Plating System?

The FDA product code for Arthrex Variable Angle (VA) Proximal Tibia Plating System is HRS.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

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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.

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