Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arthrex SutureTak Suture Anchor

K-Number: K252314 · 2025-10-29

ApplicantArthrex, Inc.
Decision Date2025-10-29
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex SutureTak Suture Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-10-29 under approval number K252314. 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 SutureTak Suture Anchor?

Arthrex SutureTak Suture Anchor is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by Arthrex, Inc.. The 510(k) number is K252314.

When was Arthrex SutureTak Suture Anchor approved by the FDA?

Arthrex SutureTak Suture Anchor received FDA 510(k) clearance on 2025-10-29, under approval number K252314.

What company makes Arthrex SutureTak Suture Anchor?

Arthrex SutureTak Suture Anchor is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex SutureTak Suture Anchor?

The FDA product code for Arthrex SutureTak 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)

Other Devices by Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161782Arthrex Univers Revers Shoulder Prosthesis System K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters

View all 168 devices →

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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.

↑