Cleared Traditional

K190069 - SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

K190069 is an FDA 510(k) clearance for SixFix Hexapod Fixator and Deformity An..., 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 119-day FDA review.

K190069 · Arrowhead De, LLC · Orthopedic device
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May 2019
Decision
119d
Days
Class 2
Risk

K190069 is an FDA 510(k) clearance for the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS). 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 May 14, 2019 after a review of 119 days - within the typical 510(k) review window.

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 - K190069

510(k) Number K190069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2019
Decision Date May 14, 2019
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 K190069.
Pitkar External Fixation System
K190486 · S.H.Pitkar Orthotools Pvt. , Ltd. · Oct 2019
AutoStrut
K191241 · Orthospin · Aug 2019
Revolution External Plating System
K181630 · New Standard Device Dba Metalogix · May 2019
OIC External Fixation System
K183682 · Orthopaedic Implant Company · Apr 2019
Austin Miller Large External Fixation System
K181528 · Austin Miller Trauma, LLC · Feb 2019
Hoffmann LRF System
K182968 · Stryker GmbH · Jan 2019