DeviceClearance

Arthrex FiberButton— 510(k) K260018

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K260018 for Arthrex FiberButton, Substantially Equivalent on 2026-06-26. Applicant: Arthrex, Inc.. Device class: 2.

Summary

The Arthrex FiberButton is filed under MBI, nondegradable soft tissue fixation fasteners. The record gives no model numbers, sizes, or description beyond the name.

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

Arthrex filed from Naples, Florida. The decision came 172 calendar days after FDA received it (January 5 to June 26, 2026).

Clearance details

Applicant
Arthrex, Inc.
Product code
Product code MBI
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 ↗

Recent devices under product code MBI

view all

More clearances from Arthrex, Inc.

view all

Adverse events under product code MBI

product code MBI
Injury
3,163
Malfunction
13,006
Other
2
Total
16,171

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.