Cleared Traditional

K141278 - MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

K141278 is an FDA 510(k) clearance for MAGEC SPINAL BRACING AND DISTRACTION SYSTEM, 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 312-day FDA review.

K141278 · Ellipse Technologies, Inc. · Orthopedic device
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Mar 2015
Decision
312d
Days
Class 2
Risk

K141278 is an FDA 510(k) clearance for the 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 March 24, 2015 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Ellipse Technologies, Inc. devices

FDA 510(k) Submission Details - K141278

510(k) Number K141278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2014
Decision Date March 24, 2015
Days to Decision 312 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
190d slower than avg
Panel avg: 122d · This submission: 312d
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.