Cleared Special

K250526 - Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (FDA 510(k) Clearance)

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

K250526 · Arthrex, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
18d
Days
Class 2
Risk

K250526 is an FDA 510(k) clearance for the Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 14, 2025 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Arthrex, Inc. devices

Submission Details

510(k) Number K250526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2025
Decision Date March 14, 2025
Days to Decision 18 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
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 218
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K250526.
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BioBrace® Extra-Articular Ligament Augmentation Kit
K252946 · Conmed Corporation · Oct 2025
OSSIOfiber® Interference Screw
K252022 · OSSIO , Ltd. · Aug 2025
OSSIOfiber® Suture Anchor
K251309 · OSSIO , Ltd. · May 2025