Cleared Special

K112237 - MICROSUTURE ANCHORS

K112237 is the FDA 510(k) clearance for MICROSUTURE ANCHORS by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 29-day FDA review.

K112237 · Arthrex, Inc. · Orthopedic device
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Sep 2011
Decision
29d
Days
Class 2
Risk

K112237 is an FDA 510(k) clearance for the MICROSUTURE ANCHORS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on September 2, 2011 after a review of 29 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 Arthrex, Inc. devices

Submission Details

510(k) Number K112237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2011
Decision Date September 02, 2011
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K112237.
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · Smith & Nephew, Inc. · Oct 2011
ORTHOLOC(TM) BONE SCREWS
K112772 · Wrightmedicaltechnologyinc · Oct 2011
ZIMMER PERIARTICULAR SCREWS
K111447 · Zimmer, Inc. · Oct 2011
SLIC SCREW REPAIR SYSTEM
K111608 · Acumed, LLC · Aug 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · Synthes (Usa) · Jul 2011
AAP CANNULATED SCREWS
K111316 · Aap Implantate AG · Jul 2011