FDA Product Code PGM: Growing Rod System
Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion.
Leading manufacturers include Globus Medical, Inc., OrthoPediatrics Corp. and BAAT Medical Products B.V..
FDA 510(k) Cleared Growing Rod System Devices (Product Code PGM)
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 Review Time
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 →