# K140178: Ellipse Magec Spinal Bracing and Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse Technologies, Inc.
- Decided: Feb 27, 2014 after 34 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
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Harrington Rod System, Preamendment: named in the summary without a submission number

## Most influential descendants
- K140613: Magec Spinal Bracing and Distraction System (2014), 6 descendants of its own
- 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

## Recalls of this device
- Jun 25, 2019 · Class II · Z-0528-2022: Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

## Indications for use
The Eilipse 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/K140178
Methodology: https://510kreport.com/methodology