Related Experiment Video
Updated: Dec 11, 2025
07:33
In Vitro Application of a Wireless Sensor in Flexion-Extension Gap Balance of Unicompartmental Knee Arthroplasty
Published on: May 5, 2023
947
FDA public workshop: Orthopaedic sensing, measuring, and advanced reporting technology (SMART) devices
Andrew P Baumann1, Colin O'Neill1, Michael C Owens1
1Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Summary
Smart orthopaedic implants offer data-gathering capabilities, enhancing patient monitoring beyond traditional methods. Collaborative efforts are needed to navigate the benefits and risks of this evolving smart technology in orthopaedics.
Area of Science:
- Orthopaedic Surgery
- Biomedical Engineering
- Medical Device Technology
Background:
- Traditional orthopaedic devices lack post-operative communication, relying on limited episodic monitoring.
- The orthopaedic field is increasingly exploring the integration of smart technology for enhanced patient care.
Purpose of the Study:
- To explore the potential benefits and risks of incorporating smart technology into orthopaedic implants.
- To foster dialogue on the responsible development and implementation of smart orthopaedic devices.
Main Methods:
- Discussion of engineering, clinical, patient, cybersecurity, and regulatory aspects of smart orthopaedic devices.
- Analysis of presentations and discussions from the 2018 FDA public workshop on SMART devices.
Main Results:
- Smart orthopaedic implants can gather and exchange data, enabling automated sensing and reporting of patient or device parameters.
- The integration of advanced technology presents potential benefits but also introduces new patient risks.
Conclusions:
- A collective, responsible approach is necessary for integrating smart technology into musculoskeletal disease care.
- Understanding the benefit-risk profile of smart orthopaedic devices is crucial for safety and effectiveness.
