Cleared Traditional

K150885 - MAGEC 2 Spinal Bracing and Distraction System

K150885 is an FDA 510(k) clearance for MAGEC 2 Spinal Bracing and Distraction ..., manufactured by Ellipse Technologies, Incorporated. The device is a Class 2 Orthopedic device with product code PGN cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K150885 · Ellipse Technologies, Incorporated · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
57d
Days
Class 2
Risk

K150885 is an FDA 510(k) clearance for the MAGEC 2 Spinal Bracing and Distraction System. Classified as Growing Rod System- Magnetic Actuation (product code PGN), Class II - Special Controls.

Submitted by Ellipse Technologies, Incorporated (Irvine, US). The FDA issued a Cleared decision on May 29, 2015 after a review of 57 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.

FDA 510(k) Submission Details - K150885

510(k) Number K150885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2015
Decision Date May 29, 2015
Days to Decision 57 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 122d · This submission: 57d
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.

Regulatory Peers - PGN Growing Rod System- Magnetic Actuation

All 8
Devices cleared under the same product code (PGN) and FDA review panel - the closest regulatory comparables to K150885.
MAGEC® System
K171791 · Nuvasive Specialized Orthopedics, Incorporated · Aug 2017
MAGEC® Spinal Bracing and Distraction System
K160352 · Nuvasive Specialized Orthopedics, Inc. · Oct 2016
MAGEC® Spinal Bracing and Distraction System
K161751 · Nuvasive Specialized Orthopedics, Inc. · Sep 2016
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K141278 · Ellipse Technologies, Inc. · Mar 2015
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K140613 · Ellipse Technologies, Inc. · Sep 2014
ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K140178 · Ellipse Technologies, Inc. · Feb 2014