Tag Archive | 510(k)

BMJ Studies Address Safety of Devices and Alendronate

BMJ recently published two studies of interest to orthopaedists:

  • After analyzing data from more than 200 cardiovascular, orthopaedic, and neurologic devices approved in both the US and European Union (EU), Hwang et al. found that those approved in the EU first were nearly three times as likely to trigger a safety alert or experience a recall than those first approved in the US. Finding further that trial results were published for fewer than half of approved devices considered “major innovations,” the authors call for “greater regulatory transparency” so physicians and patients can make better-informed decisions. Interestingly, Figure 2 in this study showed that the FDA approval time for orthopaedic devices was faster than ortho-device approval times in the EU. However, a JBJS study earlier this year found that devices approved via the FDA’s “quick” 510(k) process were 11.5 times more likely to be recalled than those cleared through the longer and more stringent FDA pathway.
  • In the second BMJ article, a registry-based case-control study, Abrahamsen et al. found that the long-term use of the bisphosphonate alendronate does not increase the risk for atypical femoral fractures (either subtrochanteric or femoral shaft), while protecting against hip fractures. After applying some sophisticated statistical analyses, the authors estimated that 38 patients with ≥5 years of alendronate adherence would need to be treated for an additional 5 years to prevent one hip fracture, while 1449 similar patients would need to be treated to cause an atypical femoral fracture. Click here for more OrthoBuzz coverage of the relationship between bisphosphonates and atypical femoral fractures.

Lots of Ortho Device Recalls with 510(k) Process

Recalled Devices Pie Chart.gif
Most orthopaedic devices are cleared through the FDA’s 510(k) process. But an analysis in the March 16, 2016 JBJS by Day et al. revealed that 510(k)-cleared devices were 11.5 times more likely to be recalled than devices cleared through the more stringent Premarket Approval (PMA) process.

The authors encourage orthopaedic surgeons who are thinking about using a new device in patients to consider how the device was approved. “If the device was approved by the 510(k) pathway, then it may have been approved without additional clinical studies confirming efficacy or safety,” they caution.

The pie chart above shows that from November 2002 to December 2012, 41% of all recalled devices from the 20 companies with the highest number of recalls were of orthopaedic origin.