FDA product code OSF: Patient Specific Manual Orthopedic Stereotaxic System
OSF is the FDA product code for patient specific manual orthopedic stereotaxic system. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under OSF, 1 in the last five years, from 2 different applicants. The average 510(k) review took 351 days (median 345); 314 days on average over the last three years. FDA has posted 1 recall for OSF devices.
Definition
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
Classification
| Field | Value |
|---|---|
| Device name | Patient Specific Manual Orthopedic Stereotaxic System |
| 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 OSF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 345 |
| 2024 | 1 | 314 |
Compare with all 510(k) review times · Search every OSF clearance
Top OSF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgical Planning Associates, Inc. | 2 | 2024-08-08 |
| Surgical Planning Associates | 1 | 2010-12-09 |
Most recent OSF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233315 | Surgical Planning Associates, Inc. | HipXpert and HipInsight System | 2024-08-08 | 314 |
| K200384 | Surgical Planning Associates, Inc. | HipXpert 3D Display and Anchoring Application | 2021-01-28 | 345 |
| K093491 | Surgical Planning Associates | HIP SEXTANT INSTRUMENT SYSTEM | 2010-12-09 | 394 |
Recalls for OSF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-09-23.
Frequently asked questions
What is FDA product code OSF?
OSF is the FDA product code for patient specific manual orthopedic stereotaxic system. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel.
What device class is OSF?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code OSF?
Across 3 cleared submissions the average was 351 days from receipt to decision (median 345).
Which companies have the most OSF clearances?
Surgical Planning Associates, Inc. (2); Surgical Planning Associates (1).
Have OSF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-09-23.
Next steps
- Run an FDA pathway report with predicate devices for product code OSF
- Run a recall and safety report across every OSF manufacturer
- Watch product code OSF 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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