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# Implantable Orthopedic Device Reprocessing Petition
- URL: https://www.fdaweb.com/implantable-orthopedic-device-reprocessing-petition/
- Published: 2018-10-31T12:00:00.000Z
- Updated: 2026-09-15T00:41:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142712

University of Toledo Colleges of Engineering and Medicine professor **Aakash Agarwal** says FDA should stop clearing 510(k)s and approving PMAs for reprocessing of pedicle screws and other implantable orthopedic devices, and should stop clearing 510(k)s for reusable implantable orthopedic devices. A 10/31 [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2018-P-4143-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) describes in detail two ways in which Agarwal believes that implants are getting contaminated — preoperative contamination and intraoperative contamination — with references to studies he says demonstrate the issue.