Cleared Traditional

K132731 - DIGIFIX EXTERNAL FIXATION SYSTEM

K132731 is an FDA 510(k) clearance for DIGIFIX EXTERNAL FIXATION SYSTEM, manufactured by Virak Orthopedic Research, LLC. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K132731 · Virak Orthopedic Research, LLC · Orthopedic device
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Jan 2014
Decision
129d
Days
Class 2
Risk

K132731 is an FDA 510(k) clearance for the DIGIFIX EXTERNAL FIXATION SYSTEM. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Virak Orthopedic Research, LLC (Bartlett, US). The FDA issued a Cleared decision on January 10, 2014 after a review of 129 days - within the typical 510(k) review window.

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 Virak Orthopedic Research, LLC devices

FDA 510(k) Submission Details - K132731

510(k) Number K132731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2013
Decision Date January 10, 2014
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
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 - JEC Component, Traction, Invasive

All 50
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