# K241816: VerteGlide Spinal Growth Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Mar 14, 2025 after 263 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 6.

## Indications for use
The VerteGlide Spinal Growth Guidance System 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 for the following subset of patients: * Patients who may require serial magnetic resonance imaging; * Patients with small stature; * Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events; * Patients at risk for implant prominence following surgery; * Patients with hyperkyphotic spinal deformities; OR. * Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with additional spinal surgery. The VerteGlide Spinal Growth Guidance System is intended to be removed after skeletal maturity. The VerteGlide Navigation Compatible Instruments are intended to be used during the preparation and placement of the VerteGlide Spinal Growth Guidance System screws. The VerteGlide Navigation Compatible Instruments have the option to be used with or without Medtronic StealthStation@ System. Use of VerteGlide Navigation Compatible Instruments with Medtronic StealthStation@ System during spinal surgery can assist the surgeon in precisely locating anatomical structures in the VerteGlide Spinal Growth Guidance System procedures. The Medtronic StealthStation@ System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K241816
Methodology: https://510kreport.com/methodology