Cleared Traditional

K162032 - Arrowhead Mini-Rail Fixator

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

K162032 · Arrowhead De, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K162032

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
Combination Product No
PCCP Authorized No
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.

KTT Device Classification - Class 2, Special Controls

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 353
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K162032.
Hoffmann LRF System
K163656 · Stryker GmbH · Apr 2017
Dolphix® External Fixation System MR Conditional
K163323 · Citieffe S.R.L. · Mar 2017
SALVATION External Fixation System
K162033 · Wright Medical · Mar 2017
Gexfix External Fixation
K160972 · Gexfix International Corp. · Dec 2016
Hoffman LRF System
K161753 · Stryker GmbH · Nov 2016
DePuy Synthes MAXFRAME Multi-Axial Correction System
K161417 · Synthes (Usa), LLC · Nov 2016