Cleared Special

K193157 - Arthrex 3.9mm Corkscrew Suture Anchor

K193157 is the FDA 510(k) clearance for Arthrex 3.9mm Corkscrew Suture Anchor by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Special 510(k) pathway after a 28-day FDA review.

K193157 · Arthrex, Inc. · Orthopedic device
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Dec 2019
Decision
28d
Days
Class 2
Risk

K193157 is an FDA 510(k) clearance for the Arthrex 3.9mm 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 December 12, 2019 after a review of 28 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 K193157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2019
Decision Date December 12, 2019
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 162
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K193157.
Fixone Biocomposite Anchor
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K193503 · Arthrex, Inc. · Jan 2020
Parcus Knotless AP Suture Anchors
K192824 · Parcus Medical, LLC · Nov 2019
Arthrex SwiveLock Anchor
K192532 · Arthrex, Inc. · Oct 2019
Arthrex SwiveLock Anchors
K192441 · Arthrex, Inc. · Oct 2019