FDA product code OUR: Sacroiliac Joint Fixation
OUR is the FDA product code for sacroiliac joint fixation. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 132 510(k) submissions under OUR, 68 in the last five years, from 63 different applicants. The average 510(k) review took 121 days (median 90); 105 days on average over the last three years. FDA has posted 1 recall for OUR devices, 1 initiated in the last five years.
Definition
sacroiliac joint fusion
Classification
| Field | Value |
|---|---|
| Device name | Sacroiliac Joint Fixation |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OUR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 118 |
| 2018 | 7 | 86 |
| 2019 | 7 | 103 |
| 2020 | 7 | 124 |
| 2021 | 9 | 86 |
| 2022 | 14 | 204 |
| 2023 | 20 | 111 |
| 2024 | 15 | 102 |
| 2025 | 14 | 113 |
| 2026 | 5 | 100 |
Compare with all 510(k) review times · Search every OUR clearance
Top OUR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| SI-BONE, Inc. | 27 | 2026-02-11 |
| SurGenTec, LLC | 7 | 2026-08-24 |
| Zyga Technology, Inc. | 6 | 2015-08-05 |
| Life Spine, Inc. | 5 | 2024-07-29 |
| Orthofix, Inc. | 5 | 2021-03-25 |
58 more applicants have OUR clearances. See the full list in Caduvo.
Most recent OUR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261381 | SurGenTec, LLC | TiLink-L SI Joint Fusion System | 2026-08-24 | 119 |
| K260477 | Tenon Medical | CATAMARAN SI Joint Fusion System | 2026-04-08 | 55 |
| K253488 | SI-BONE, Inc. | iFuse INTRA Ti Implant System | 2026-02-11 | 110 |
| K253611 | Mcnicoll Surgical, Inc. | Falco Fusion System | 2026-01-29 | 72 |
| K252834 | 4Web Medical | Sacroiliac Joint Truss System (SJTS) | 2026-01-28 | 145 |
Recalls for OUR devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code OUR?
OUR is the FDA product code for sacroiliac joint fixation. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is OUR?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUR?
Across 132 cleared submissions the average was 121 days from receipt to decision (median 90).
Which companies have the most OUR clearances?
SI-BONE, Inc. (27); SurGenTec, LLC (7); Zyga Technology, Inc. (6); Life Spine, Inc. (5); Orthofix, Inc. (5).
Have OUR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code OUR
- Run a recall and safety report across every OUR manufacturer
- Watch product code OUR 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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