Cleared Special

K161913 - AOS Small Fragment Plating System

K161913 is an FDA 510(k) clearance for AOS Small Fragment Plating System, manufactured by Advanced Orthopaedic Solutions, Inc. (Aos). The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 115-day FDA review.

K161913 · Advanced Orthopaedic Solutions, Inc. (Aos) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
115d
Days
Class 2
Risk

K161913 is an FDA 510(k) clearance for the AOS Small Fragment Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (Aos) (Torrance, US). The FDA issued a Cleared decision on November 4, 2016 after a review of 115 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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. (Aos) devices

FDA 510(k) Submission Details - K161913

510(k) Number K161913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2016
Decision Date November 04, 2016
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 1037
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K161913.
EVOS Small Fragment Plating System
K162078 · Smith & Nephew, Inc. · Nov 2016
VLP Wrist Fracture System
K161665 · Smith & Nephew, Inc. · Nov 2016
LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
K161703 · Aap Implantate AG · Nov 2016
MatrixRIB Fixation System
K161590 · Synthes USA Products, LLC · Nov 2016
Footmotion Plating System
K161448 · Newclip Technics · Oct 2016
Ulna Plating System
K162424 · Biomet, Inc. · Oct 2016