U.S. Food and Drug Administration Monday ordered manufacturers of certain types of pedicle screw systems, known as dynamic stabilization systems, to conduct studies.
The screws are used to grip a spinal segment and serve as anchors that can then be connected with a rod and are intended to provide support to the spinal column during bone fusion.The FDA stated there are 16 dynamic stabilization systems or components on the market
According to a representative from DePuy spine, the company currently has two of those systems in market.
"We just received this notification and are evaluating how to best comply with the FDA's new requirement," said a statement released by DePuy.
Mary Beth Thorsgaard, Medtronic, said her company is going to comply fully with the FDA. It was unclear how many systems Medtronic had as of this morning.
The Times-Union contacted both Zimmer and Biomet about whether they had such systems or comments on the FDA's request. Neither responded as of press time this morning.
The studies will focus on things such as the rate the spine fuses and frequency of additional surgeries.
The FDA stated in a release that "there is not enough clinical data to determine whether these dynamic stabilization systems provide enough spinal stability to allow for complete spinal fusion, as the system components may loosen, bend or break over time."
According to the FDA, if fusion does not occur, a patient's condition could get worse and they could require more surgeries.
The FDA is requiring postmarket studies to address these potential risks for systems already on the market.
In addition, the FDA is requesting manufacturers with new dynamic stabilization systems or components to submit clinical information for agency review prior to marketing.
There will be no recommendations for changes regarding the use of dynamic stabilization systems until it collects and reviews the data.
The FDA suggested that patients who have or are considering the implantation of a dynamic stabilization system should consult with their health care practitioner.
Dynamic stabilization systems differ from traditional stabilization systems that are more rigid. Those traditional systems have been available for decades.
Dynamic stabilization systems have different design features that allow bending or rotation while still facilitating fusion.
The FDA cleared the first dynamic stabilization system component in 1997. The FDA has cleared numerous dynamic stabilization systems or components since then.
When the FDA receives the data from the studies, the agency will then determine whether things like labeling changes or more preclinical or clinical testing requirements are needed.
