Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button— 510(k) K260353

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K260353 for Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button, Substantially Equivalent on 2026-03-03. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2026-02-03
Decision date: 2026-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

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.