Cleared Special

K143125 - Orthofix True Lok Hexapod System VI.3

K143125 is the FDA 510(k) clearance for Orthofix True Lok Hexapod System VI.3 by Orthofix Srl. It is a Class 2 Orthopedic device (product code KTT) cleared through the Special 510(k) pathway after a 40-day FDA review.

K143125 · Orthofix Srl · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 Consultant

Wagoner Consulting, LLC
Cherly Wagoner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 278
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K143125.
Cardinal Health External Fixation System
K150579 · Cardinalhealth · Apr 2015
SALVATION External Fixation System
K150004 · Wrightmedicaltechnologyinc · Mar 2015
SIDEKICK EZ FRAME External Fixation System
K143220 · Wrightmedicaltechnologyinc · Jan 2015
ORTHOFIX GALAXY WRIST
K141760 · Orthofix Srl · Dec 2014
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
K142052 · Orthofix Srl · Dec 2014
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
K142520 · Smith & Nephew, Inc. · Nov 2014