Growing Rod System
The Growing Rod System is an orthopedic implant device intended for the stabilization or correction of spinal deformities in pediatric patients without the use of spinal fusion, allowing for continued spinal growth. It is an FDA Class 2 device regulated under 21 CFR 888.3070, requiring 510(k) premarket notification, within the Orthopedic (OR) medical specialty. The product code is PGM, and it is flagged as an implant due to its surgical placement along the spine.
Research product code PGM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PGM
- Device Class
- FDA class 2
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
Stabilization or correction of spinal deformities without the use of fusion.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251961 | SDS Growing Rod | Jan 15, 2026 | Substantially Equivalent | BAAT Medical Products B.V. |
| K241816 | VerteGlide Spinal Growth Guidance System | Mar 14, 2025 | Substantially Equivalent | OrthoPediatrics Corp. |
| K213196 | MARVEL Growing Rods | Dec 19, 2022 | Substantially Equivalent | Globus Medical, Inc. |
| K193224 | Daytona® Small Stature Growth Rod Conversion Set | Feb 13, 2020 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System | Sep 24, 2019 | Substantially Equivalent | Medos International SARL |
| K181068 | CREO® Stabilization System, REVERE® Stabilization System | Jun 29, 2018 | Substantially Equivalent | Globus Medical, Inc. |
| K180227 | Polaris Spinal Growth System | Mar 15, 2018 | Substantially Equivalent | Zimmer Biomet Spine, Inc. |
| K172979 | NuVasive® Growth Rod Conversion Set | Nov 06, 2017 | Substantially Equivalent | Nu Vasive, Incorporated |
| K161028 | K2M Growing Spine System | Jul 22, 2016 | Substantially Equivalent | K2m, Inc. |
| K150200 | CD HORIZON Growth Rod Conversion Set | Feb 25, 2015 | Substantially Equivalent | Medtronic Sofamor Danek USA, Incorporated |
| K142114 | Xia® Growth Rod Conversion Set | Oct 27, 2014 | Substantially Equivalent | Stryker Corporation |
| K141509 | ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS | Aug 22, 2014 | Substantially Equivalent | Medos Sarl |
| K140750 | SHILLA GROWTH GUIDANCE SYSTEM | Jul 17, 2014 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. |
| K133904 | CD HORIZON SPINAL SYSTEM GROWTH ROD SET | Feb 25, 2014 | Substantially Equivalent | Medtronic Sofamor Danek USA |
FEI Numbers
This FDA classification entry is associated with 42 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 42 registration numbers. Click on an entry to view related FDA registrations.