Data / Medical devices / Intraoperative Orthopedic Joint Assessment Aid
Intraoperative Orthopedic Joint Assessment Aid (ONN): 6 FDA-registered makers in 5 countries
6 establishments in 5 countries are registered with the FDA to make Intraoperative Orthopedic Joint Assessment Aid (product code ONN, Class 2, 21 CFR 882.4560). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on July 31, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ONN
- Device class
- 2
- Regulation
- 882.4560
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Ireland | 1 |
| United Kingdom | 1 |
| Canada | 1 |
| China | 1 |
Makers of Intraoperative Orthopedic Joint Assessment Aid
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| OrthAlign, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | July 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Depuy Ireland UC | Co. Cork Munster, Ireland | Specification developer | 1 | September 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Eventum Orthopaedics Ltd | Leeds, United Kingdom | Complaint file establishment, Manufacturer | 1 | October 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Zimmer Cas | Montreal, Quebec, Canada | Specification developer | 1 | April 4, 2007 | 0 | 0 | 0 | api.fda.gov |
| Immetech Industrial Co.,ltd | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant San Antonio, Inc. | San Antonio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.