Cleared Traditional

K141278 - MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141278 · Ellipse Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.