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 Knotless FiberTak Biceps Suture Anchor

K-Number: K222161 · 2022-08-11

ApplicantArthrex, Inc.
Decision Date2022-08-11
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Knotless FiberTak Biceps Suture Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-08-11 under approval number K222161. 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 Knotless FiberTak Biceps Suture Anchor?

Arthrex Knotless FiberTak Biceps Suture Anchor is a medical device that received FDA 510(k) clearance on 2022-08-11. It is manufactured by Arthrex, Inc.. The 510(k) number is K222161.

When was Arthrex Knotless FiberTak Biceps Suture Anchor approved by the FDA?

Arthrex Knotless FiberTak Biceps Suture Anchor received FDA 510(k) clearance on 2022-08-11, under approval number K222161.

What company makes Arthrex Knotless FiberTak Biceps Suture Anchor?

Arthrex Knotless FiberTak Biceps Suture Anchor is manufactured by Arthrex, Inc..

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

The FDA product code for Arthrex Knotless FiberTak Biceps 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 NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

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.

↑