Have PMA applications on spine devices changed since 2000? 5 key trends


A new study published in The Spine Journal examines premarket approval for class III spine devices in the United States from 2000 to 2015.

The researchers identified PMA applications over the study period from the FDA's Orthopaedic and Rehabilitation Devices Panel from the Federal Register and examined the PMA application database. There were 21 devices that met the study criteria. The researchers found:


1. There were 76.2 percent that received approval; another 47.6 percent of the applications went to panel.


2. The most commonly approved devices were for arthroplasty, representing 52.4 percent of the devices. The arthroplasty devices were also least likely to go to a panel, but if they did they were the most likely to be approved.


3. The biologics devices were most likely to go to the panel and had the lowest rate of approval.


4. From 2000 to 2009, there wasn't a decrease in spinal devices approved.


5. All of the devices were studied in a pivotal clinical trial, and all were randomized control trials except for one. There were 20 trials that had two-arm non-inferiority designs.


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