Cleared Traditional

K153233 - Galaxy UNYCO System

K153233 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 58-day FDA review.

K153233 · Orthofix Srl · Orthopedic device
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Jan 2016
Decision
58d
Days
Class 2
Risk

K153233 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 January 6, 2016 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthofix Srl devices

Submission Details

510(k) Number K153233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2015
Decision Date January 06, 2016
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K153233.
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