# K141278: Magec Spinal Bracing and Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse Technologies, Inc.
- Decided: Mar 24, 2015 after 312 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.
No later device cites it as a predicate yet.
0 of 2 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 5.

## 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/K141278
Methodology: https://510kreport.com/methodology