FDA 510(k)

Q-FIX ULTRA All-Suture Anchor

K-Number: K232457 · 2023-09-08

Decision Date2023-09-08

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Q-FIX ULTRA All-Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K232457. 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 ULTRA All-Suture Anchor?

Q-FIX ULTRA All-Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Smith & Nephew. The 510(k) number is K232457.

When did Q-FIX ULTRA All-Suture Anchor receive FDA 510(k) clearance?

Q-FIX ULTRA All-Suture Anchor received FDA 510(k) clearance on 2023-09-08, under 510(k) number K232457.

Who is the listed applicant for Q-FIX ULTRA All-Suture Anchor?

The FDA 510(k) record lists Smith & Nephew as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q-FIX ULTRA All-Suture Anchor?

The FDA product code for Q-FIX ULTRA All-Suture Anchor is MBI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02440672JOURNEY™ II CR Total Knee SystemACTIVE_NOT_RECRUITING NCT03247023Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint ReplacementTERMINATED NCT03985839Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and HipCOMPLETED NCT04325022Safety and Effectiveness Study of OR3O™ Dual Mobility System in THAACTIVE_NOT_RECRUITING NCT04849884To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.COMPLETED NCT05444465Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness TearsRECRUITING

Other records listing Smith & Nephew as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

View all 125 devices →

Related Devices (Code: MBI)

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy K261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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.