FDA product code SBF: Orthopedic Augmented Reality
SBF is the FDA product code for orthopedic augmented reality. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel. FDA has cleared 43 510(k) submissions under SBF, 36 in the last five years, from 16 different applicants. The average 510(k) review took 142 days (median 111); 112 days on average over the last three years. FDA has posted 2 recalls for SBF devices, 2 initiated in the last five years.
Definition
An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as augmented reality stereoscopic images to intraoperatively augment the users field of view.
Classification
| Field | Value |
|---|---|
| Device name | Orthopedic Augmented Reality |
| 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 SBF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 255 |
| 2020 | 2 | 142 |
| 2021 | 4 | 160 |
| 2022 | 7 | 233 |
| 2023 | 7 | 109 |
| 2024 | 6 | 102 |
| 2025 | 13 | 124 |
| 2026 | 3 | 109 |
Compare with all 510(k) review times · Search every SBF clearance
Top SBF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medacta International S.A. | 10 | 2026-01-09 |
| Augmedics, Ltd. | 7 | 2026-07-31 |
| Pixee Medical | 5 | 2025-03-20 |
| Surgical Theater, Inc. | 3 | 2025-09-29 |
| Mr Surgical Solutions, LLC | 3 | 2025-09-10 |
11 more applicants have SBF clearances. See the full list in Caduvo.
Most recent SBF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261854 | Augmedics, Ltd. | xvision Spine system | 2026-07-31 | 58 |
| K253805 | Pixee Medical S.A.S. | Knee+ | 2026-04-24 | 147 |
| K252847 | Medacta International S.A. | NextAR Hip Platform | 2026-01-09 | 123 |
| K251639 | Augmedics, Ltd. | xvision Spine system | 2025-10-03 | 127 |
| K252054 | Surgical Theater, Inc. | SpineAR SNAP (SyncAR Spine) | 2025-09-29 | 90 |
Recalls for SBF devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-07-13.
| Year | Recalls |
|---|---|
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code SBF?
SBF is the FDA product code for orthopedic augmented reality. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel.
What device class is SBF?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code SBF?
Across 43 cleared submissions the average was 142 days from receipt to decision (median 111).
Which companies have the most SBF clearances?
Medacta International S.A. (10); Augmedics, Ltd. (7); Pixee Medical (5); Surgical Theater, Inc. (3); Mr Surgical Solutions, LLC (3).
Have SBF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2026-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code SBF
- Run a recall and safety report across every SBF manufacturer
- Watch product code SBF 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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