Cleared Special

K160409 - AOS Anterolateral Proximal Humeral Plate

K160409 is the FDA 510(k) clearance for AOS Anterolateral Proximal Humeral Plate by Advanced Orthopaedic Solutions, Inc.. It is a Class 2 Orthopedic device (product code KTW) cleared through the Special 510(k) pathway after a 28-day FDA review.

K160409 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Mar 2016
Decision
28d
Days
Class 2
Risk

K160409 is an FDA 510(k) clearance for the AOS Anterolateral Proximal Humeral Plate. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (Torrance, US). The FDA issued a Cleared decision on March 15, 2016 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 Advanced Orthopaedic Solutions, Inc. devices

Submission Details

510(k) Number K160409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2016
Decision Date March 15, 2016
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component
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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 23
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K160409.
PK High Tibial Osteotomy Correction System
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Phantom Small Bone Intramedullary Nail System
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ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
K122541 · Orthofix Srl · Sep 2012
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
K080109 · Synthes (Usa) · Mar 2008
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
K062920 · Orthofix Srl · Nov 2006
LEFORTE SYSTEM BONE PLATE
K023360 · Jeil Medical Corporation · Oct 2002