Cleared Traditional

K142052 - ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT

K142052 is an FDA 510(k) clearance for ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT, manufactured by Orthofix Srl. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K142052 · Orthofix Srl · Orthopedic device
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Dec 2014
Decision
130d
Days
Class 2
Risk

K142052 is an FDA 510(k) clearance for the ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Orthofix Srl (Wilmington, US). The FDA issued a Cleared decision on December 5, 2014 after a review of 130 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K142052

510(k) Number K142052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2014
Decision Date December 05, 2014
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 361
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