Cleared Special

Q-FIX ULTRA All-Suture Anchor (K232457) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232457 · Smith & Nephew · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
25d
Days
Class 2
Risk

K232457 is an FDA 510(k) clearance for the Q-FIX ULTRA All-Suture Anchor. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Smith & Nephew (Andover, US). The FDA issued a Cleared decision on September 8, 2023 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew devices

Submission Details

510(k) Number K232457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2023
Decision Date September 08, 2023
Days to Decision 25 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 321
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K232457.
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