# K180227: Polaris Spinal Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Biomet Spine, Inc.
- Decided: Mar 15, 2018 after 48 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: 5 generations back to K013962 (2002). 7 ancestors in all.
1 later device descends from it; 1 cites 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)
- K133904: CD Horizon Spinal System Growth Rod Set, Medtronic Sofamor Danek USA (2014) Summary page 6.

## Most influential descendants
- K233105: RESPONSE™ Rib and Pelvic System (2024), 0 descendants of its own

## Indications for use
The Polaris Spinal Growth System is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome. The Polaris Spinal Growth System may be used with any cleared traditional Polaris Spinal System construct, including any cleared Polaris Spinal System compatibilities.

Source page: https://510kreport.com/device/K180227
Methodology: https://510kreport.com/methodology