Cleared Traditional

K170146 - Galaxy UNYCO System

K170146 is the FDA 510(k) clearance for Galaxy UNYCO System by Orthofix Srl. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K170146 · Orthofix Srl · Orthopedic device
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Oct 2017
Decision
268d
Days
Class 2
Risk

K170146 is an FDA 510(k) clearance for the Galaxy UNYCO System. 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 October 12, 2017 after a review of 268 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 Orthofix Srl devices

Submission Details

510(k) Number K170146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2017
Decision Date October 12, 2017
Days to Decision 268 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
146d slower than avg
Panel avg: 122d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Cheryl 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 K170146.
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Orthofix TrueLok Hexapod System (TL-HEX) V2.0
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Hoffmann LRF System
K163656 · Stryker GmbH · Apr 2017
Hoffman LRF System
K161753 · Stryker GmbH · Nov 2016