ArthroTAK Tendon Anchor Kit— 510(k) K262809

Name: FDA 510(k) clearance K262809
Creator: U.S. Food and Drug Administration
Published: 2026-09-02

Substantially Equivalent

ArthroTAK, LLC

FDA 510(k) clearance K262809 for ArthroTAK Tendon Anchor Kit, Substantially Equivalent on 2026-09-02. Applicant: ArthroTAK, LLC. Device class: 2.

Summary

ArthroTAK Tendon Anchor Kit is from ArthroTAK, LLC, filed under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). The record doesn't list what's in the kit.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k). The decision was Substantially Equivalent.

ArthroTAK filed from Missoula, Montana. The decision came 26 calendar days after FDA received it (August 7 to September 2, 2026).

Clearance details

Applicant: ArthroTAK, LLC
Product code: Product code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-08-07
Decision date: 2026-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Missoula, MT, US

Download summary PDF View on FDA.gov ↗

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K263352 — TeKBrace Knotless Anchor2026-10-21
K261869 — Integrity Retractable Implant Inserter (6000127)2026-09-17
K253065 — Aevumed SUPERCYNCH Button System2026-09-02

More clearances from ArthroTAK, LLC

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K252635 — ArthroTAK Tendon Anchor Kit2026-05-01

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.