FDA product code ONN: Intraoperative Orthopedic Joint Assessment Aid
ONN is the FDA product code for intraoperative orthopedic joint assessment aid. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel. FDA has cleared 18 510(k) submissions under ONN, 6 in the last five years, from 7 different applicants. The average 510(k) review took 172 days (median 146); 80 days on average over the last three years. FDA has posted 8 recalls for ONN devices.
Definition
Measurement and interpretation of orthopedic joint information.
Classification
| Field | Value |
|---|---|
| Device name | Intraoperative Orthopedic Joint Assessment Aid |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | OR — Orthopedic |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for ONN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 259 |
| 2018 | 1 | 107 |
| 2020 | 3 | 101 |
| 2022 | 1 | 177 |
| 2024 | 2 | 90 |
| 2025 | 1 | 29 |
| 2026 | 2 | 120 |
Compare with all 510(k) review times · Search every ONN clearance
Top ONN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthosensor, Inc. | 8 | 2020-08-25 |
| Orthalign, Inc. | 3 | 2026-07-31 |
| Eventum Orthopaedics, Ltd. | 2 | 2025-09-09 |
| Synvasive Technology, Inc. | 2 | 2011-03-22 |
| These Three Medical, LLC | 1 | 2022-09-15 |
2 more applicants have ONN clearances. See the full list in Caduvo.
Most recent ONN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262253 | Orthalign, Inc. | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | 2026-07-31 | 29 |
| K253507 | Orthalign, Inc. | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | 2026-06-02 | 211 |
| K252524 | Eventum Orthopaedics, Ltd. | Quadsense (Quadsense and Quadsense Pro) | 2025-09-09 | 29 |
| K241298 | Eventum Orthopaedics, Ltd. | QUADSENSE | 2024-10-04 | 149 |
| K242616 | Orthalign, Inc. | Lantern® Hip | 2024-10-03 | 30 |
Recalls for ONN devices
8 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-07-12.
| Year | Recalls |
|---|---|
| 2018 | 6 |
Frequently asked questions
What is FDA product code ONN?
ONN is the FDA product code for intraoperative orthopedic joint assessment aid. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel.
What device class is ONN?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONN?
Across 18 cleared submissions the average was 172 days from receipt to decision (median 146).
Which companies have the most ONN clearances?
Orthosensor, Inc. (8); Orthalign, Inc. (3); Eventum Orthopaedics, Ltd. (2); Synvasive Technology, Inc. (2); These Three Medical, LLC (1).
Have ONN devices been recalled?
Yes: 8 product recalls across 3 recall events; the most recent began 2018-07-12.
Next steps
- Run an FDA pathway report with predicate devices for product code ONN
- Run a recall and safety report across every ONN manufacturer
- Watch product code ONN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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