Cleared Special

K241435 - Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue (FDA 510(k) Clearance)

Also includes:
Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue

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

K241435 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
30d
Days
Class 2
Risk

K241435 is an FDA 510(k) clearance for the Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue. 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, Inc. (Andover, US). The FDA issued a Cleared decision on June 20, 2024 after a review of 30 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, Inc. devices

Submission Details

510(k) Number K241435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2024
Decision Date June 20, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
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 590
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K241435.
ArthroTAK Tendon Anchor Kit
K252635 · ArthroTAK, LLC · May 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
K260921 · Tigon Medical · Apr 2026
Arthrex FiberTak Suture Anchor
K260561 · Arthrex, Inc. · Mar 2026
Grappler Suture Anchor PCFD Tether System
K253886 · Paragon 28, Inc. · Mar 2026
SINEFIX
K254176 · BAAT Medical Products B.V. · Mar 2026
Trax EX Anchor
K251750 · Trax Surgical, Inc. · Mar 2026