FDA 510(k) orthopedic devices include implants, instruments and systems used in musculoskeletal surgery and rehabilitation. The FDA review panel code is OR.
Key categories:
With 17,685 submissions, this is one of the largest 510(k) categories. Data sourced from FDA 510(k) public files. Updated monthly.
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 117d |
| All-time average (cleared) | 122d |
| Not Substantially Equivalent (denied) | 357d |
FDA review times for Orthopedic submissions have remained consistent, averaging 117 days for cleared devices. Denied submissions averaged 357 days before receiving a Not Substantially Equivalent determination.
This page lists all 17816 medical devices in the Orthopedic specialty that have been submitted to the FDA through the 510(k) premarket notification process. Joint implants, surgical navigation, bone fixation and robotic surgery systems.
This page lists 17816 medical devices in the Orthopedic specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 17799 were cleared as substantially equivalent to a predicate device. Average FDA review time: 122 days. Records from 1976 to the present.
You can use this list to:
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific orthopedic device? Search by device name, K-number or manufacturer.
Search all Orthopedic 510(k) devices