PGM · Class II · 21 CFR 888.3070

FDA Product Code PGM: Growing Rod System

Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion.

Leading manufacturers include Globus Medical, Inc., BAAT Medical Products B.V. and Medtronic Sofamor Danek USA, Inc..

14
Total
14
Cleared
126d
Avg days
2014
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 233d recently vs 108d historically

FDA 510(k) Cleared Growing Rod System Devices (Product Code PGM)

14 devices
1–14 of 14
Cleared Jan 15, 2026
SDS Growing Rod
K251961
BAAT Medical Products B.V.
Orthopedic · 203d
Cleared Mar 14, 2025
VerteGlide Spinal Growth Guidance System
K241816
OrthoPediatrics Corp.
Orthopedic · 263d
Cleared Dec 19, 2022
MARVEL™ Growing Rods
K213196
Globus Medical, Inc.
Orthopedic · 446d
Cleared Feb 13, 2020
Daytona® Small Stature Growth Rod Conversion Set
K193224
SeaSpine Orthopedics Corporation
Orthopedic · 83d
Cleared Sep 24, 2019
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
K191212
Medos International SARL
Orthopedic · 141d
Cleared Jun 29, 2018
CREO® Stabilization System, REVERE® Stabilization System
K181068
Globus Medical, Inc.
Orthopedic · 67d
Cleared Mar 15, 2018
Polaris Spinal Growth System
K180227
Zimmer Biomet Spine, Inc.
Orthopedic · 48d
Cleared Nov 06, 2017
NuVasive® Growth Rod Conversion Set
K172979
Nu Vasive, Incorporated
Orthopedic · 40d
Cleared Jul 22, 2016
K2M Growing Spine System
K161028
K2m, Inc.
Orthopedic · 101d
Cleared Oct 27, 2014
Xia® Growth Rod Conversion Set
K142114
Stryker Corporation
Orthopedic · 84d
Cleared Jul 17, 2014
SHILLA GROWTH GUIDANCE SYSTEM
K140750
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 114d

About Product Code PGM - Regulatory Context

510(k) Submission Activity

14 total 510(k) submissions under product code PGM since 2014, with 14 receiving FDA clearance (average review time: 126 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PGM Product Code

Recent submissions under PGM have taken an average of 233 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.

PGM devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →