Cleared Traditional

K162032 - Arrowhead Mini-Rail Fixator

K162032 is the FDA 510(k) clearance for Arrowhead Mini-Rail Fixator by Arrowhead De, LLC. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K162032 · Arrowhead De, LLC · Orthopedic device
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Feb 2017
Decision
214d
Days
Class 2
Risk

K162032 is an FDA 510(k) clearance for the Arrowhead Mini-Rail Fixator. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Arrowhead De, LLC (Collierville, US). The FDA issued a Cleared decision on February 21, 2017 after a review of 214 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.

View all Arrowhead De, LLC devices

Submission Details

510(k) Number K162032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2016
Decision Date February 21, 2017
Days to Decision 214 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
92d slower than avg
Panel avg: 122d · This submission: 214d
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 272
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K162032.
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Hoffmann LRF System
K163656 · Stryker GmbH · Apr 2017
Hoffman LRF System
K161753 · Stryker GmbH · Nov 2016
Hoffmann LRF (Limb Reconstruction Frame) System
K153377 · Stryker GmbH · Apr 2016
SALVATION(R) External Fixation System
K153635 · Wrightmedicaltechnologyinc · Jan 2016