Cleared Traditional

K122415 - X-FIX DYNAMIC EXTERNAL DISTRACTOR

K122415 is an FDA 510(k) clearance for X-FIX DYNAMIC EXTERNAL DISTRACTOR, manufactured by Arex USA, LLC. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K122415 · Arex USA, LLC · Orthopedic device
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Mar 2013
Decision
219d
Days
Class 2
Risk

K122415 is an FDA 510(k) clearance for the X-FIX DYNAMIC EXTERNAL DISTRACTOR. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Arex USA, LLC (Edgewater, US). The FDA issued a Cleared decision on March 15, 2013 after a review of 219 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Arex USA, LLC devices

FDA 510(k) Submission Details - K122415

510(k) Number K122415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2012
Decision Date March 15, 2013
Days to Decision 219 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 122d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 117
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K122415.
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INTRAOSSEOUS FIXATION SYSTEM
K120165 · Orthohelix Surgical Designs, Inc. · Apr 2012
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
K112990 · Arthrex, Inc. · Dec 2011
PCL TIGHTROPE
K110123 · Arthrex, Inc. · Apr 2011