FDA product code PGM: Growing Rod System
PGM is the FDA product code for growing rod system. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel. FDA has cleared 14 510(k) submissions under PGM, 3 in the last five years, from 13 different applicants. The average 510(k) review took 126 days (median 84); 233 days on average over the last three years.
Definition
Stabilization or correction of spinal deformities without the use of fusion.
Classification
| Field | Value |
|---|---|
| Device name | Growing Rod System |
| Device class | Class II |
| Regulation | 21 CFR 888.3070 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PGM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 40 |
| 2018 | 2 | 58 |
| 2019 | 1 | 141 |
| 2020 | 1 | 83 |
| 2022 | 1 | 446 |
| 2025 | 1 | 263 |
| 2026 | 1 | 203 |
Compare with all 510(k) review times · Search every PGM clearance
Top PGM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Globus Medical, Inc. | 2 | 2022-12-19 |
| BAAT Medical Products B.V. | 1 | 2026-01-15 |
| OrthoPediatrics Corp. | 1 | 2025-03-14 |
| SeaSpine Orthopedics Corporation | 1 | 2020-02-13 |
| Medos International SARL | 1 | 2019-09-24 |
8 more applicants have PGM clearances. See the full list in Caduvo.
Most recent PGM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251961 | BAAT Medical Products B.V. | SDS Growing Rod | 2026-01-15 | 203 |
| K241816 | OrthoPediatrics Corp. | VerteGlide Spinal Growth Guidance System | 2025-03-14 | 263 |
| K213196 | Globus Medical, Inc. | MARVEL Growing Rods | 2022-12-19 | 446 |
| K193224 | SeaSpine Orthopedics Corporation | Daytona® Small Stature Growth Rod Conversion Set | 2020-02-13 | 83 |
| K191212 | Medos International SARL | 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 | 2019-09-24 | 141 |
Recalls for PGM devices
openFDA lists no recalls for product code PGM.
Frequently asked questions
What is FDA product code PGM?
PGM is the FDA product code for growing rod system. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel.
What device class is PGM?
Class II, regulation 21 CFR 888.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGM?
Across 14 cleared submissions the average was 126 days from receipt to decision (median 84).
Which companies have the most PGM clearances?
Globus Medical, Inc. (2); BAAT Medical Products B.V. (1); OrthoPediatrics Corp. (1); SeaSpine Orthopedics Corporation (1); Medos International SARL (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PGM
- Run a recall and safety report across every PGM manufacturer
- Watch product code PGM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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