# K251961: SDS Growing Rod

- Pathway: 510(k) (Traditional)
- Applicant: BAAT Medical Products B.V.
- Decided: Jan 15, 2026 after 203 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)
- K140750: Shilla Growth Guidance System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.

## Indications for use
The SDS Growing Rod is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome.

Source page: https://510kreport.com/device/K251961
Methodology: https://510kreport.com/methodology