Cleared Traditional

K143204 - AOS Clavicle Intramedullary Device

K143204 is the FDA 510(k) clearance for AOS Clavicle Intramedullary Device by Advanced Orthopaedic Solutions, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K143204 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
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Jun 2015
Decision
208d
Days
Class 2
Risk

K143204 is an FDA 510(k) clearance for the AOS Clavicle Intramedullary Device. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (Torrance, US). The FDA issued a Cleared decision on June 3, 2015 after a review of 208 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Orthopaedic Solutions, Inc. devices

Submission Details

510(k) Number K143204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2014
Decision Date June 03, 2015
Days to Decision 208 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 122d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 319
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K143204.
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