Cleared Traditional

K200123 - Accessories for the SixFix® Hexapod Fixator

K200123 is an FDA 510(k) clearance for Accessories for the SixFix Hexapod 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 245-day FDA review.

K200123 · Arrowhead De, LLC · Orthopedic device
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Sep 2020
Decision
245d
Days
Class 2
Risk

K200123 is an FDA 510(k) clearance for the Accessories for the SixFix® Hexapod 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 September 22, 2020 after a review of 245 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 - K200123

510(k) Number K200123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2020
Decision Date September 22, 2020
Days to Decision 245 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
123d slower than avg
Panel avg: 122d · This submission: 245d
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 K200123.
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation
K201253 · Smith & Nephew · Dec 2020
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K202762 · Smith & Nephew, Inc. · Nov 2020
Pitkar DeftFix System
K200728 · S.H.Pitkar Orthotools Pvt. , Ltd. · Oct 2020
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K193368 · Wishbone Medical, Inc. · Sep 2020
FusionFrame Ring Lock System
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Dynex Micro
K202143 · Vilex, LLC · Sep 2020