Wednesday, October 14, 2009

The FDA Orders Dynamic Stabilization Companies to Collect Data

On October 5th, the FDA ordered 12 spinal implant manufacturers to initiate collecting post-market data on how well their dynamic stabilization devices fare in doing what they were cleared for, as an adjunct to spinal fusion. The 16 dynamic stabilization systems include;

Zimmer Dynesys DTO
Medtronic CD Horizon Legacy and Agile
Scient'x Isobar
Paradigm Spine DSS
BioSpine BioFlex
Globus Medical Protex and Transition
DePuy Expedium Polymer Rods
Synthes Spine Ngarde
Alphatec Zodiac
Applied Spine Stabilimaxx BAR
Ulrich Cosmic and SSCS
Vertiflex Dynabolt

The FDA is establishing a new post-market requirement and asking for pre-market data to be included in future 510(k) submissions. Under this new order, companies will need to collect data on the rates of fusion, adverse events and additional surgeries as compared to traditional pedicle screw fixation. The onus is being placed on these manufacturers to determine the cause of device failure.

Based on the post-market data, the FDA will consider whether labeling changes or additional requirements will be necessary to move forward. At this juncture there is no time table for data collection requirements. The FDA invokes its authority under Section 522 which allows the agency to mandate post market data collection under threat, fine or seizure.

1 comment:

  1. I understand that this order is for dynamic systems, however is it expected that these same pre-market data requirements for 510(k)s might be imposed on fusion systems in development as well (i.e. new screw/rod systems or cages)?