FDA 510(k) Orthopedic Devices
About Orthopedic Devices
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:
- Joint replacement implants - hip, knee, shoulder and ankle prostheses
- Bone fixation systems - plates, screws, nails and external fixators
- Spinal implants - cages, rods, pedicle screws and disc replacements
- Surgical navigation - image-guided and robotic-assisted orthopedic surgery
- Bone grafts and substitutes - synthetic and allograft bone repair materials
With 17,685 submissions, this is one of the largest 510(k) categories. Data sourced from FDA 510(k) public files. Updated monthly.
FDA 510(k) Cleared Orthopedic Devices
This page lists all 1214 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.
- 1213 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 115 days.
- Records available from 2021 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 1214 medical devices in the Orthopedic specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 1213 were cleared as substantially equivalent to a predicate device. Average FDA review time: 115 days. Records from 2021 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to orthopedic
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
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