PGM — Growing Rod System Class II
FDA product code PGM covers "Growing Rod System", a Class II medical device regulated under 21 CFR 888.3070. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PGM
- Device Class
- Class II
- Regulation Number
- 888.3070
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Stabilization or correction of spinal deformities without the use of fusion.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251961 | baat medical products | SDS Growing Rod | January 15, 2026 |
| K241816 | orthopediatrics | VerteGlide Spinal Growth Guidance System | March 14, 2025 |
| K213196 | globus medical | MARVEL Growing Rods | December 19, 2022 |
| K193224 | seaspine orthopedics corporation | Daytona® Small Stature Growth Rod Conversion Set | February 13, 2020 |
| K191212 | medos international sarl | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fen | September 24, 2019 |
| K181068 | globus medical | CREO® Stabilization System, REVERE® Stabilization System | June 29, 2018 |
| K180227 | zimmer biomet spine | Polaris Spinal Growth System | March 15, 2018 |
| K172979 | nu vasive, incorporated | NuVasive® Growth Rod Conversion Set | November 6, 2017 |
| K161028 | k2m | K2M Growing Spine System | July 22, 2016 |
| K150200 | medtronic sofamor danek usa, incorporated | CD HORIZON Growth Rod Conversion Set | February 25, 2015 |
| K142114 | stryker corporation | Xia® Growth Rod Conversion Set | October 27, 2014 |
| K141509 | medos sarl | ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS | August 22, 2014 |
| K140750 | medtronic sofamor danek usa | SHILLA GROWTH GUIDANCE SYSTEM | July 17, 2014 |
| K133904 | medtronic sofamor danek usa | CD HORIZON SPINAL SYSTEM GROWTH ROD SET | February 25, 2014 |