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FDA 510(k)

Arthrex Nano FiberTak Suture Anchor

K-Number: K254229 · 2026-03-02

ApplicantArthrex, Inc.
Decision Date2026-03-02
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Nano FiberTak Suture Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2026-03-02 under approval number K254229. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Nano FiberTak Suture Anchor?

Arthrex Nano FiberTak Suture Anchor is a medical device that received FDA 510(k) clearance on 2026-03-02. It is manufactured by Arthrex, Inc.. The 510(k) number is K254229.

When was Arthrex Nano FiberTak Suture Anchor approved by the FDA?

Arthrex Nano FiberTak Suture Anchor received FDA 510(k) clearance on 2026-03-02, under approval number K254229.

What company makes Arthrex Nano FiberTak Suture Anchor?

Arthrex Nano FiberTak Suture Anchor is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Nano FiberTak Suture Anchor?

The FDA product code for Arthrex Nano FiberTak Suture Anchor is MBI.

Related Clinical Trials

NCT06829667 Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability COMPLETED NCT05753891 Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective) TERMINATED

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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