DeviceClearance

Arthrex Beaming System— 510(k) K254215

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K254215 for Arthrex Beaming System, Substantially Equivalent on 2026-05-08. Applicant: Arthrex, Inc.. Device class: 2.

Summary

Arthrex's Arthrex Beaming System is filed under HWC, bone fixation screws.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).

Arthrex filed from Naples, Florida. The decision came 130 calendar days after receipt (December 29, 2025 to May 8, 2026).

Clearance details

Applicant
Arthrex, Inc.
Product code
Product code HWC
Device class
Class 2
Regulation
21 CFR 888.3040
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 HWC

product code HWC
Death
20
Injury
15,910
Malfunction
8,192
Other
1
Total
24,123

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.