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)

Q-Fix Suture Anchor

K-Number: K172165 · 2017-08-17

ApplicantArthroCare Corporation
Decision Date2017-08-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Q-Fix Suture Anchor is a medical device manufactured by ArthroCare Corporation. It received FDA 510(k) clearance on 2017-08-17 under approval number K172165. 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 Q-Fix Suture Anchor?

Q-Fix Suture Anchor is a medical device that received FDA 510(k) clearance on 2017-08-17. It is manufactured by ArthroCare Corporation. The 510(k) number is K172165.

When was Q-Fix Suture Anchor approved by the FDA?

Q-Fix Suture Anchor received FDA 510(k) clearance on 2017-08-17, under approval number K172165.

What company makes Q-Fix Suture Anchor?

Q-Fix Suture Anchor is manufactured by ArthroCare Corporation.

What is the FDA product code for Q-Fix Suture Anchor?

The FDA product code for Q-Fix Suture Anchor is MBI.

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 ArthroCare Corporation

K161481Ambient HipVac 50 Wand with Integrated Finger Switches K162126Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) K162074Werewolf RF20000 Controller, FLOW 50 Wand K153675Paragon T2 Wand with Integrated Cable K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches

View all 17 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.

↑