# K140613: Magec Spinal Bracing and Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse Technologies, Inc.
- Decided: Sep 18, 2014 after 192 days
- Product code: PGN (Growing Rod System- Magnetic Actuation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K140178 (2014). 1 ancestor in all.
6 later devices descend from it; 2 cite 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)
- K140178: Ellipse Magec Spinal Bracing and Distraction System, Ellipse Technologies, Inc. (2014) Summary page 6.

## Most influential descendants
- K150885: MAGEC 2 Spinal Bracing and Distraction System (2015), 5 descendants of its own
- K160352: MAGEC® Spinal Bracing and Distraction System (2016), 3 descendants of its own
- K161751: MAGEC® Spinal Bracing and Distraction System (2016), 3 descendants of its own
- K171791: MAGEC® System (2017), 2 descendants of its own
- K201543: MAGEC® System (2020), 1 descendant of its own

## Indications for use
The Ellipse MAGEC Spinal Bracing and Distraction 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/K140613
Methodology: https://510kreport.com/methodology