# K213196: MARVEL™ Growing Rods

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Dec 19, 2022 after 446 days
- Product code: PGM (Growing Rod System)
- 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: 20 generations back to K853033 (1985). 460 ancestors in all.
No later device cites it as a predicate yet.
1 of 461 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181068: CREO® Stabilization System, REVERE® Stabilization System, Globus Medical, Inc. (2018) Summary page 4.

## Indications for use
MARVEL" Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.

Source page: https://510kreport.com/device/K213196
Methodology: https://510kreport.com/methodology