DeviceClearance

FiberTape Button— 510(k) K260405

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K260405 for FiberTape Button, Substantially Equivalent on 2026-03-09. Applicant: Arthrex, Inc.. Device class: 2.

Summary

Arthrex's FiberTape Button is filed under MBI, nondegradable soft tissue fixation fasteners. The record doesn't list sizes or models.

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

Arthrex filed from Naples, Florida. The decision came 28 calendar days after FDA received it (February 9 to March 9, 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
Special
Location
Naples, FL, US
Download summary PDFView on FDA.gov ↗

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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.