Cleared Special

Orthofix True Lok Hexapod System VI.3 (K143125) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K143125 · Orthofix Srl · Orthopedic device
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Dec 2014
Decision
40d
Days
Class 2
Risk

K143125 is an FDA 510(k) clearance for the Orthofix True Lok Hexapod System VI.3. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Orthofix Srl (Bussolengo, IT). The FDA issued a Cleared decision on December 10, 2014 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthofix Srl devices

Submission Details

510(k) Number K143125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2014
Decision Date December 10, 2014
Days to Decision 40 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 122d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

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 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K143125.
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XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K141697 · Zimmer, Inc. · Sep 2014
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K131413 · Zimmer, Inc. · Jan 2014