Cleared Traditional

K113770 - ORTHOFIX GALAXY FIXATION SYSTEM

K113770 is the FDA 510(k) clearance for ORTHOFIX GALAXY FIXATION SYSTEM by Orthofix Srl. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K113770 · Orthofix Srl · Orthopedic device
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Sep 2012
Decision
257d
Days
Class 2
Risk

K113770 is an FDA 510(k) clearance for the ORTHOFIX GALAXY FIXATION SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Orthofix Srl (Oregon City, US). The FDA issued a Cleared decision on September 4, 2012 after a review of 257 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 K113770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2011
Decision Date September 04, 2012
Days to Decision 257 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
135d slower than avg
Panel avg: 122d · This submission: 257d
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 Peers - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K113770.
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K113327 · Stryker Corp. · Mar 2012
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
K111786 · Stryker Corp. · Jan 2012