Cleared Traditional

K181528 - Austin Miller Large External Fixation System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181528 · Austin Miller Trauma, LLC · Orthopedic device
Feb 2019
Decision
262d
Days
Class 2
Risk

K181528 is an FDA 510(k) clearance for the Austin Miller Large External Fixation System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Austin Miller Trauma, LLC (Germantown, US). The FDA issued a Cleared decision on February 28, 2019 after a review of 262 days - an extended review 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: 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.

Submission Details

510(k) Number K181528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2018
Decision Date February 28, 2019
Days to Decision 262 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 116d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple 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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 24
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K181528.
QuikFix External Fixator: Knee-Spanning Pack
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Monkey Rings External Ring Fixation System
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Medusa Orthopedics Boa External Fixation System
K252555 · Medusa Orthopedics, LLC · Nov 2025
The Response Ortho Smart Fixator - Hexapod System
K252625 · Response Ortho Solutions, LLC · Nov 2025