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.