DeviceClearance

Arthrex FiberTak Suture Anchor— 510(k) K260561

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K260561 for Arthrex FiberTak Suture Anchor, Substantially Equivalent on 2026-03-20. Applicant: Arthrex, Inc.. Device class: 2.

Summary

Arthrex's Arthrex FiberTak Suture Anchor is filed under MBI, nondegradable soft tissue fixation fasteners. The record doesn't list anchor sizes or suture options.

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

Arthrex filed from Naples, Florida. The decision came 29 calendar days after receipt (February 19 to March 20, 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.