DeviceClearance

Arthrex Humeral Nails— 510(k) K252016

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K252016 for Arthrex Humeral Nails, Substantially Equivalent on 2026-03-20. Applicant: Arthrex, Inc.. Device class: 2.

Summary

Arthrex's Arthrex Humeral Nails are filed under HSB, intramedullary fixation rods and accessories. The record doesn't list nail lengths or diameters.

Class II, 21 CFR 888.3020. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).

Arthrex filed from Naples, Florida. The decision came 266 calendar days after receipt (June 27, 2025 to March 20, 2026).

Clearance details

Applicant
Arthrex, Inc.
Product code
Product code HSB
Device class
Class 2
Regulation
21 CFR 888.3020
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Naples, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HSB

product code HSB
Death
49
Injury
12,083
Malfunction
6,561
Other
1
Total
18,694

Source: openFDA MAUDE database, through . 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.