Cleared Special

K191226 - Arthrex SwiveLock Suture Anchor

K191226 is the FDA 510(k) clearance for Arthrex SwiveLock Suture Anchor by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Special 510(k) pathway after a 35-day FDA review.

K191226 · Arthrex, Inc. · Orthopedic device
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Jun 2019
Decision
35d
Days
Class 2
Risk

K191226 is an FDA 510(k) clearance for the Arthrex SwiveLock 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 June 11, 2019 after a review of 35 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 K191226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2019
Decision Date June 11, 2019
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 K191226.
Arthrex SwiveLock Anchor
K192532 · Arthrex, Inc. · Oct 2019
Arthrex SwiveLock Anchors
K192441 · Arthrex, Inc. · Oct 2019
HEALIX ADVANCE SP BIOCOMPOSITE Anchor
K191242 · Medos International SARL · Aug 2019
Parcus Twist AP Suture Anchors
K183501 · Parcus Medical, LLC · Mar 2019
Rotium Bioresorbable Wick
K183236 · Nanofiber Solutions, LLC · Mar 2019
HEALIX ADVANCE Anchor with DYNACORD Suture
K183506 · Medos International SARL · Feb 2019