Arthrex FiberButton— 510(k) K260018

Name: FDA 510(k) clearance K260018
Creator: U.S. Food and Drug Administration
Published: 2026-06-26

Substantially Equivalent

Arthrex, Inc.

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

Clearance details

Applicant: Arthrex, Inc.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-01-05
Decision date: 2026-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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K261770 — Suture Button Repair System2026-07-29
K261632 — Thunderbolt System2026-07-20

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K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System2026-06-25
K253931 — Arthrex Bioabsorbable PushLock Suture Anchors2026-05-28
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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, 2020-01-01 through 2026-04-23. 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.