Cleared Special

K151732 - Arthrex Fracture Plates

K151732 is an FDA 510(k) clearance for Arthrex Fracture 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 63-day FDA review.

K151732 · Arthrex, Inc. · Orthopedic device
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Aug 2015
Decision
63d
Days
Class 2
Risk

K151732 is an FDA 510(k) clearance for the Arthrex Fracture Plates. 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 August 28, 2015 after a review of 63 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 - K151732

510(k) Number K151732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2015
Decision Date August 28, 2015
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 K151732.
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K152142 · Normed Medizin-Technik GmbH · Sep 2015
TOTAL COMPRESSION PLATING (TCP) SYSTEM
K151442 · Wrightmedicaltechnologyinc · Sep 2015
PRCT2
K143721 · Fx Solutions · Aug 2015
Airlock® osteosynthesis plate system
K151277 · Novastep · Aug 2015
Conventus PRS System
K151379 · Conventus Orthopaedics, Inc. · Aug 2015