Cleared Traditional

K160352 - MAGEC® Spinal Bracing and Distraction System

K160352 is an FDA 510(k) clearance for MAGEC Spinal Bracing and Distraction System, manufactured by Nuvasive Specialized Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code PGN cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K160352 · Nuvasive Specialized Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
256d
Days
Class 2
Risk

K160352 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 Nuvasive Specialized Orthopedics, Inc. (Alisa Viejo, US). The FDA issued a Cleared decision on October 21, 2016 after a review of 256 days - an extended review 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: 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.

FDA 510(k) Submission Details - K160352

510(k) Number K160352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2016
Decision Date October 21, 2016
Days to Decision 256 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
134d slower than avg
Panel avg: 122d · This submission: 256d
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 K160352.
MAGEC Spinal Bracing and Distraction System
K233593 · Nuvasive Specialized Orthopedics, Incorporated · Feb 2024
MAGEC® System
K201543 · Nuvasive Specialized Orthopedics, Inc. · Jul 2020
MAGEC® System
K171791 · Nuvasive Specialized Orthopedics, Incorporated · Aug 2017
MAGEC® Spinal Bracing and Distraction System
K161751 · Nuvasive Specialized Orthopedics, Inc. · Sep 2016
MAGEC 2 Spinal Bracing and Distraction System
K150885 · Ellipse Technologies, Incorporated · May 2015
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K141278 · Ellipse Technologies, Inc. · Mar 2015