# K201543: MAGEC® System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: Jul 30, 2020 after 51 days
- Product code: PGN (Growing Rod System- Magnetic Actuation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K140178 (2014). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171791: MAGEC® System, Nuvasive Specialized Orthopedics, Incorporated (2017) Summary page 5.
- K150885: MAGEC 2 Spinal Bracing and Distraction System, Ellipse Technologies, Incorporated (2015) Summary page 5.
- K140178: Ellipse Magec Spinal Bracing and Distraction System, Ellipse Technologies, Inc. (2014) Summary page 5.

## Most influential descendants
- K233593: MAGEC Spinal Bracing and Distraction System (2024), 0 descendants of its own

## Recalls of this device
- Nov 1, 2022 · Class II · Z-0559-2023: During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situati

## Indications for use
The MAGEC® System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.

Source page: https://510kreport.com/device/K201543
Methodology: https://510kreport.com/methodology