VerteGlide Spinal Growth Guidance System
FDA 510(k) K241816 · OrthoPediatrics Corp.
510(k) numberK241816
Submission
- Device name
- VerteGlide Spinal Growth Guidance System
- Applicant
- OrthoPediatrics Corp.
Warsaw, IN, US - Received
- June 24, 2024
- Decision date
- March 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGM – Growing Rod System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Stabilization or correction of spinal deformities without the use of fusion.
Other 510(k)s with product code PGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251961 | SDS Growing RodPGM · Traditional | BAAT Medical Products B.V. | 01/15/2026SE |
| K213196 | MARVEL Growing RodsPGM · Traditional | Globus Medical, Inc. | 12/19/2022SE |
| K193224 | Daytona® Small Stature Growth Rod Conversion SetPGM · Traditional | SeaSpine Orthopedics Corporation | 02/13/2020SE |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…PGM · Traditional | Medos International SARL | 09/24/2019SE |
| K181068 | CREO® Stabilization System, REVERE® Stabilization SystemPGM · Traditional | Globus Medical, Inc. | 06/29/2018SE |
| K180227 | Polaris Spinal Growth SystemPGM · Traditional | Zimmer Biomet Spine, Inc. | 03/15/2018SE |
| K172979 | NuVasive® Growth Rod Conversion SetPGM · Traditional | Nu Vasive, Incorporated | 11/06/2017SE |
| K161028 | K2M Growing Spine SystemPGM · Traditional | K2m, Inc. | 07/22/2016SE |
| K150200 | CD HORIZON Growth Rod Conversion SetPGM · Special | Medtronic Sofamor Danek USA, Incorporated | 02/25/2015SE |
| K142114 | Xia® Growth Rod Conversion SetPGM · Traditional | Stryker Corporation | 10/27/2014SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate SystemHRS · Traditional | 04/30/2026SE |
| K252600 | Pediatric Plating Platform I Small-MiniHRS · Traditional | 10/09/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | 06/24/2025SE |
| K243963 | Pediatric Plating Platform HipHRS · Traditional | 04/29/2025SE |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurHSB · Special | 04/01/2025SE |
| K243798 | Orthex External Fixation SystemKTT · Traditional | 03/07/2025SE |
| K233105 | RESPONSE Rib and Pelvic SystemMDI · Traditional | 01/20/2024SE |
| K231266 | Pediatric Nailing Platform TibiaHSB · Traditional | 08/21/2023SE |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw SystemNKB · Special | 03/23/2023SE |
| K223786 | Orthex External Fixation SystemKTT · Traditional | 02/10/2023SE |
Questions and answers
When was VerteGlide Spinal Growth Guidance System cleared by the FDA?
VerteGlide Spinal Growth Guidance System (K241816) received a 510(k) decision of Substantially Equivalent on March 14, 2025, 263 days after the submission was received.
What is the product code of K241816?
The FDA product code is PGM – Growing Rod System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.