# K171791: MAGEC® System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Incorporated
- Decided: Aug 31, 2017 after 76 days
- Product code: PGN (Growing Rod System- Magnetic Actuation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K140178 (2014). 5 ancestors in all.
2 later devices descend 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)
- K150885: MAGEC 2 Spinal Bracing and Distraction System, Ellipse Technologies, Incorporated (2015) Summary page 5.
- K161751: MAGEC® Spinal Bracing and Distraction System, Nuvasive Specialized Orthopedics, Inc. (2016) Summary page 5.
- K160352: MAGEC® Spinal Bracing and Distraction System, Nuvasive Specialized Orthopedics, Inc. (2016) Summary page 5.
- K140178: Ellipse Magec Spinal Bracing and Distraction System, Ellipse Technologies, Inc. (2014) Summary page 5.

## Most influential descendants
- K201543: MAGEC® System (2020), 1 descendant of its own
- K233593: MAGEC Spinal Bracing and Distraction System (2024), 0 descendants of its own

## Recalls of this device
- Apr 3, 2025 · Class II · Z-1657-2025: Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
- Feb 13, 2020 · Class II · Z-1898-2020: Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Ti

## 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/K171791
Methodology: https://510kreport.com/methodology