Avanti Distal Elbow ORIF System— 510(k) K261145

Name: FDA 510(k) clearance K261145
Creator: U.S. Food and Drug Administration
Published: 2026-05-09

Substantially Equivalent

Avanti Orthopaedics, LLC

FDA 510(k) clearance K261145 for Avanti Distal Elbow ORIF System, Substantially Equivalent on 2026-05-09. Applicant: Avanti Orthopaedics, LLC. Device class: 2.

Summary

Avanti Orthopaedics' Avanti Distal Elbow ORIF System is filed under HRS, bone fixation plates. The record doesn't expand "ORIF".

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it was an Abbreviated 510(k).

Avanti filed from Wilmington, Delaware. Review took 32 calendar days (April 7 to May 9, 2026).

Clearance details

Applicant: Avanti Orthopaedics, LLC
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-04-07
Decision date: 2026-05-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wilmington, DE, US

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.