FDA product code OSN: Software For Diagnosis/Treatment
OSN is the FDA product code for software for diagnosis/treatment. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 4 510(k) submissions under OSN, 2 in the last five years, from 4 different applicants. The average 510(k) review took 124 days (median 130); 93 days on average over the last three years. FDA has posted 2 recalls for OSN devices, 1 initiated in the last five years.
Definition
Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Classification
| Field | Value |
|---|---|
| Device name | Software For Diagnosis/Treatment |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OSN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 166 |
| 2022 | 1 | 65 |
| 2026 | 1 | 93 |
Compare with all 510(k) review times · Search every OSN clearance
Top OSN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Disior, Ltd. | 1 | 2026-02-26 |
| Smith & Nephew, Inc. | 1 | 2022-08-25 |
| Arrowhead Medical Device Technologies, LLC | 1 | 2018-08-13 |
| Orthohub, Inc. | 1 | 2014-08-25 |
Most recent OSN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253764 | Disior, Ltd. | ENOS Software Guided External Fixation System | 2026-02-26 | 93 |
| K221792 | Smith & Nephew, Inc. | Acute QC Strut and Components | 2022-08-25 | 65 |
| K180539 | Arrowhead Medical Device Technologies, LLC | Deformity Analysis and Correction Software (DACS) and Instrumentation | 2018-08-13 | 166 |
| K140550 | Orthohub, Inc. | ORTHOHUB EXTERNAL FIXATOR SOFTWARE | 2014-08-25 | 174 |
Recalls for OSN devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-09-12.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code OSN?
OSN is the FDA product code for software for diagnosis/treatment. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is OSN?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code OSN?
Across 4 cleared submissions the average was 124 days from receipt to decision (median 130).
Which companies have the most OSN clearances?
Disior, Ltd. (1); Smith & Nephew, Inc. (1); Arrowhead Medical Device Technologies, LLC (1); Orthohub, Inc. (1).
Have OSN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-09-12.
Next steps
- Run an FDA pathway report with predicate devices for product code OSN
- Run a recall and safety report across every OSN manufacturer
- Watch product code OSN 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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