# K172979: NuVasive® Growth Rod Conversion Set

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Nov 6, 2017 after 40 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: 6 generations back to K013962 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K142114: Xia® Growth Rod Conversion Set, Stryker Corporation (2014) Summary page 5.

## Indications for use
The NuVasive Growth Rod Conversion Set 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 associated with thoracic insufficiency, including early-onset scoliosis. The growth rod conversion implants may be used with Armada, Reline, or Reline 4.5-5.0 rod constructV ranging in diameter from 4.5mm to 6.35mm. The NuVasive Growth Rod Conversion Set is not intended to be used in conjunction with staples.

Source page: https://510kreport.com/device/K172979
Methodology: https://510kreport.com/methodology