Cleared Traditional

K163014 - AOS Small Bone Nailing System

K163014 is an FDA 510(k) clearance for AOS Small Bone Nailing System, manufactured by Advanced Orthopaedic Solutions, Inc. (Aos). The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K163014 · Advanced Orthopaedic Solutions, Inc. (Aos) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
88d
Days
Class 2
Risk

K163014 is an FDA 510(k) clearance for the AOS Small Bone Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (Aos) (Torrance, US). The FDA issued a Cleared decision on January 24, 2017 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K163014

510(k) Number K163014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2016
Decision Date January 24, 2017
Days to Decision 88 days
Submission Type Traditional
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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 511
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K163014.
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Renovo Life Small Bone IM Nail System
K161254 · Renovo Life, LLC · Nov 2016