Cleared Special

K150456 - Arthrex Plates, Screws, and Staples

K150456 is an FDA 510(k) clearance for Arthrex Plates, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 68-day FDA review.

K150456 · Arthrex, Inc. · Orthopedic device
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Apr 2015
Decision
68d
Days
Class 2
Risk

K150456 is an FDA 510(k) clearance for the Arthrex Plates, Screws, and Staples. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 29, 2015 after a review of 68 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

FDA 510(k) Submission Details - K150456

510(k) Number K150456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2015
Decision Date April 29, 2015
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 1225
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K150456.
BIOFOAM Bone Wedge
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APTUS Foot System
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Acumed Ankle Plating System
K143385 · Acumed, LLC · Apr 2015