Cleared Traditional

K182466 - AOS Calcaneal Plating System

K182466 is the FDA 510(k) clearance for AOS Calcaneal Plating System by Advanced Orthopaedic Solutions. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K182466 · Advanced Orthopaedic Solutions · Orthopedic device
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Oct 2018
Decision
50d
Days
Class 2
Risk

K182466 is an FDA 510(k) clearance for the AOS Calcaneal 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 (Torrance, US). The FDA issued a Cleared decision on October 30, 2018 after a review of 50 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. 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.

View all Advanced Orthopaedic Solutions devices

Submission Details

510(k) Number K182466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2018
Decision Date October 30, 2018
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K182466.
Stratum™ Foot Plating System
K182201 · Nextremity Solutions, Inc. · Nov 2018
DePuy Synthes Trauma Orthopedic Plates and Screws
K180310 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Nov 2018
Medline Unite Mini Plates and Screws
K181820 · Medline Industries, Inc. · Nov 2018
ANTHEM Fracture System
K180554 · Globus Medical, Inc. · Oct 2018
Titanium TomoFix Medial High Tibia Plate Anatomical
K180213 · Synthes USA Products, LLC · Oct 2018
AxSOS 3 Ti
K181091 · Stryker GmbH · Oct 2018