Cleared Traditional

K140178 - ELLIPSE MAGEC SPINAL BRACING AND DISTRA...

K140178 is an FDA 510(k) clearance for ELLIPSE MAGEC SPINAL BRACING AND DISTRA..., manufactured by Ellipse Technologies, Inc.. The device is a Class 2 Orthopedic device with product code PGN cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K140178 · Ellipse Technologies, Inc. · Orthopedic device
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Feb 2014
Decision
34d
Days
Class 2
Risk

K140178 is an FDA 510(k) clearance for the ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM. Classified as Growing Rod System- Magnetic Actuation (product code PGN), Class II - Special Controls.

Submitted by Ellipse Technologies, Inc. (Irvine, US). The FDA issued a Cleared decision on February 27, 2014 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ellipse Technologies, Inc. devices

FDA 510(k) Submission Details - K140178

510(k) Number K140178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2014
Decision Date February 27, 2014
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGN Device Classification - Class 2, Special Controls

Product Code PGN Growing Rod System- Magnetic Actuation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion, Using Non-invasive Methods To Adjust The Spinal Rod.
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.