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Updated: Jan 20, 2026

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Reverse Total Shoulder Arthroplasty
Published on: July 5, 2011
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回想FDA批准的肩和肘部设备的趋势
Johnlevi S Lazaro1, Denise Bion2, Luke S Austin3
1Department of Orthopedic Surgery, Jefferson Health New Jersey, Stratford, NJ, USA.
Journal of shoulder and elbow surgery
|January 18, 2026
概括
骨科肩膀和肘部设备的召回率为19.1%,主要是由于II类设备的设计缺陷,通过510(k) 清除. 由于市场前测试的限制,外科医生应对新技术保持谨慎.
科学领域:
- 整形外科手术 整形外科手术
- 医疗器械监管法规 医疗器械监管法规
- 生物医学工程 生物医学工程
背景情况:
- 医疗器械的批准取决于分类和风险评估.
- 根据批准类型,骨科设备面临更高的召回风险.
- 本研究的重点是分析肩膀和肘部设备的召回风险.
研究的目的:
- 分析骨科肩膀和肘部医疗器械召回的风险.
- 确定设备召回的常见原因和分类.
- 评估随着时间的推移,FDA清除和召回率的趋势.
主要方法:
- 美国食品和药物管理局 (FDA) 数据库的回顾性审查.
- 清除和召回的肩膀和肘部设备的识别,不包括非骨科设备.
- 召回原因的分类 (设计,制造等) 和描述性的统计分析.
主要成果:
- 在1979-2025年期间,通过510k) 清除了669个肩膀和肘部装置.
- 128个设备 (19.1%) 经历了至少一次召回.
- 第二类召回最常见,主要原因是设备设计缺陷 (骨折,磨损,松动).
结论:
- 自1979年以来,肩和肘部设备的空隙,主要是通过510(k的II类,增加了.
- 没有设备通过市场前批准 (PMA) 或De Novo途径获得批准.
- 由于设计缺陷而导致的高召回率凸显了510 (k) 预售测试的局限性,敦促外科医生对新技术保持谨慎.
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