510(k) · Cleared
ClearedVerteGlide Spinal Growth Guidance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrthoPediatrics Corp. · PGM Growing Rod System
Cleared on Mar 14, 2025 as substantially equivalent to K140750 (Medtronic Sofamor Danek USA, Inc., 2014) after a 263-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- Mar 14, 2025
- Review
- 263 days
- Class
- Class II
- Product code
- PGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K013962 (2002). 8 ancestors in all, the oldest K961633 (1996). No later device cites it as a predicate yet.
- Root · 6 generations backK013962 Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 5 generations backK042453 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004
- 4 generations backK042962 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK121764 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2012
- 2 generations backK133904 CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA · 2014
- 1 generation backK140750 Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK241816 VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013962 | Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −5 | K042453 | Modification to Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| −4 | K042962 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K121764 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2012 | — |
| −2 | K133904 | CD Horizon Spinal System Growth Rod Set | Medtronic Sofamor Danek USA | 2014 | — |
| −1 | K140750 | Shilla Growth Guidance System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| 0 (this device) | K241816 | VerteGlide Spinal Growth Guidance System | OrthoPediatrics Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGM device
- #1 K251961 SDS Growing Rodscore 12.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140750 | Shilla Growth Guidance SystemSummary page 6…e Device and Reference Device Substantial equivalence is claimed to the following predicate device: Primary Predicate Device: - SHILLA™ Growth Guidance System (K140750, Medtronic Sofamor Danek USA, Inc) This submission also includes the following reference device: Reference Device: - R… | 2014 |
| † | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K140750.
How does its category compare?
All PGM devicesPGM Growing Rod System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PGM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGM
81in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGM
No recall names PGM since 2007.
Adverse event reports per year · PGM
7in 2025
MAUDE reports naming product code PGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 4 | 81 | 0 | 5 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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: *…
Read the full statement (267 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241816: VerteGlide Spinal Growth Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241816
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026