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FDA-Cleared Artificial Intelligence Medical Devices in Orthopaedic Surgery
Branden Lee1, Mitchell Jay, Henry Fox
1From the Department of Orthopaedic Surgery, Johns Hopkins Medicine (Mr. Lee, Dr. Fox, Dr. Padley, and Dr. Levin); School of Medicine, Johns Hopkins University (Mr. Lee and Mr. Jay); Carey Business School, Johns Hopkins University, Baltimore, MD (Dr. Dai); Hopkins Business of Health Initiative, Johns Hopkins University, Washington, DC (Dr. Dai), and School of Nursing, Johns Hopkins University, Baltimore, MD (Dr. Dai).
Summary
Artificial intelligence (AI) and machine learning in orthopaedic surgery are rapidly advancing. A review of FDA-cleared devices shows increasing adoption, but highlights the need for improved clinical evaluation and regulatory standards for safe implementation.
Area of Science:
- Orthopaedic Surgery
- Medical Device Innovation
- Artificial Intelligence in Medicine
Background:
- Artificial intelligence (AI) and machine learning (ML) offer significant potential to enhance medical care in orthopaedic surgery.
- Existing research often focuses on future applications, leaving a gap in understanding currently approved AI/ML medical devices (AIMDs).
- A comprehensive analysis of FDA-cleared AIMDs in orthopaedics is needed to assess current trends and regulatory status.
Purpose of the Study:
- To conduct a comprehensive analysis of FDA-cleared AI/ML-based medical devices (AIMDs) for orthopaedic surgery.
- To categorize these devices by indication, subspecialty, AI architecture, and commercialization strategy.
- To evaluate the evolution of AIMD clearances and clinical testing requirements over time.
Main Methods:
- Retrospective analysis of 70 FDA-cleared AIMDs for orthopaedic surgery indications as of February 2025.
- Categorization based on indicated use, orthopaedic subspecialty, development history, AI architecture, and commercialization approach.
- Analysis of manufacturer status, acquisition history, and country of headquarters for commercialized devices.
Main Results:
- AIMD clearances in orthopaedics have surged, with a 3-year moving average increasing from 3.0 devices/year (2017-2019) to 16.6 (2022-2024).
- Deep learning is the dominant AI technique (57.3% of 2022-2024 approvals), with spine surgery being the most common subspecialty (42.9%).
- While initial clearances often lacked clinical testing (62.2% from 2017-2019), this rate decreased significantly (19.7% from 2022-2024), though only 8.6% underwent prospective trials.
Conclusions:
- AI is a rapidly growing field in orthopaedic surgery, evidenced by increasing FDA clearances.
- There is a trend towards greater clinical testing of AIMDs, moving away from devices lacking any validation.
- Enhanced regulatory safeguards and robust clinical evaluation standards are crucial for the evidence-based adoption and safe use of AI in orthopaedics.
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