# K233593: MAGEC Spinal Bracing and Distraction System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Incorporated
- Decided: Feb 6, 2024 after 90 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: 6 generations back to K140178 (2014). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201543: MAGEC® System, Nuvasive Specialized Orthopedics, Inc. (2020) Summary page 4.
- K161751: MAGEC® Spinal Bracing and Distraction System, Nuvasive Specialized Orthopedics, Inc. (2016) Summary page 4.
- K140613: Magec Spinal Bracing and Distraction System, Ellipse Technologies, Inc. (2014) Summary page 4.

## Indications for use
The MAGEC Spinal Bracing and Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) secondary to early-onset scoliosis 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/K233593
Methodology: https://510kreport.com/methodology