Cleared Special

K170650 - Orthofix TrueLok Hexapod System (TL-HEX) V2.0

K170650 is an FDA 510(k) clearance for Orthofix TrueLok Hexapod System (TL-HEX..., manufactured by Orthofix Srl. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 68-day FDA review.

K170650 · Orthofix Srl · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
68d
Days
Class 2
Risk

K170650 is an FDA 510(k) clearance for the Orthofix TrueLok Hexapod System (TL-HEX) V2.0. 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 May 10, 2017 after a review of 68 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.

FDA 510(k) Submission Details - K170650

510(k) Number K170650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2017
Decision Date May 10, 2017
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Wagoner Consulting, LLC
Cheryl Wagonar

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 404
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K170650.
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K163323 · Citieffe S.R.L. · Mar 2017
SALVATION External Fixation System
K162033 · Wright Medical · Mar 2017
K170650 · Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Download PDF FDA Summary Orthofix Srl