Cleared Traditional

K113770 - ORTHOFIX GALAXY FIXATION SYSTEM

K113770 is an FDA 510(k) clearance for ORTHOFIX GALAXY FIXATION SYSTEM, 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 257-day FDA review.

K113770 · Orthofix Srl · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K113770

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.

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 372
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K113770.
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HOFFMANN 3
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XTRAFIX EXTERNAL FIXATION SYSTEM
K113383 · Extraortho, Inc. · Jun 2012
EXTERNAL FIXATOR ST.A R 90 F4
K113384 · Citieffe · May 2012