FDA product code · Orthopedic · Class 2
ONN: Intraoperative Orthopedic Joint Assessment Aid
ONN is FDA's product code for "Intraoperative Orthopedic Joint Assessment Aid": a Class 2 device classified under 21 CFR 882.4560, reviewed by the Orthopedic panel.
510(k) review time for ONN
Across 10 510(k) clearances under ONN decided from 2018-01-01 to 2026-10-06, the median was 104 days from FDA receipt to decision. Half took between 30 and 166 days, and 80% were decided within 173 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 30 |
| Median | 104 |
| 75th percentile | 166 |
| 80th percentile | 173 |
| 90th percentile | 180 |
| Slowest | 211 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
ONN in the public FDA record
| Device recalls | 8 |
|---|
Counts of records, not of devices or events. Adverse event reports for ONN are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite ONN
No FDA recognized consensus standard cites ONN by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.