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FDA Approval and Recall Trends for Orthopaedic Devices: A 21-year Analysis
Frederick S. Rozenshteyn, BS; David J. Park, MS; Nana Owusu-Sarpong, BS; Charles S. Day, MD, MBA
Orthopaedics, Beth Israel Deaconess Medical Center, Boston, MA

Introduction: The FDA utilizes two major pathways to approve medical devices. The first is the Premarket Approval Application (PMA) which requires clinical trials and safety data for a device to be approved. The second is the Premarket Notification 510(k) review, which requires no clinical trials if the product is shown to be substantially equivalent to an existing device. Recently, orthopaedic and hand surgery device manufacturers have experienced grand lawsuits for device recalls. Given the number of highly publicized recalls, we hypothesize that orthopaedic and hand surgery devices are more likely to be approved through the FDA's less regulated 510(k) review.

Methods: Using the FDA's public database, we aggregated PMA and 510(k) device approvals from 1992-2012 for all specialties, orthopaedics, and hand surgery. Device recalls were then obtained from the FDA's recalls database. We evaluated the top 20 companies contributing to recall from 2002-2012.

Results: From 1992 to 2012, PMA approvals for all medical specialties increased by 88 devices/year, while 510(k) approvals decreased by 96 devices/year (Figure 1). However, PMA approvals for orthopaedics decreased by 0.44 devices/year, while 510(k) approvals increased by 12 devices/year (Figure 1). Hand surgery devices followed the same 510(k) trend as orthopaedic devices. There were significant differences in PMA approval trends (P<0.001) and 510(k) approval trends (P<0.001) between all specialties and orthopaedics. Five of the top 20 companies contributing to recall from 2002-2012, including the top three, were orthopaedic and hand surgery device manufacturers, accounting for 44% of recall within these 20 companies (Figure 2). These five companies accounted for 15% of total recall during this 10-year period.

Conclusion: Over the past 2 years, while the medical device industry has shifted towards utilizing the safer PMA review, the orthopaedic and hand surgery device industry has been approving devices primarily via the 510(k) review. In the last decade, orthopaedic and hand surgery device manufacturers were the main contributors to recall. As healthcare providers, we are concerned that many orthopaedic and hand surgery devices are introduced without proper safety and efficacy data. There remain critical issues around device approval processes that must be addressed to provide better care.


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