SI-BONE, Inc.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “SI-BONE, Inc.” (first 2008, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 96 days. Since 2017 the median was 96 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 88 |
| 2013 | 2 | 131 |
| 2014 | 1 | 91 |
| 2015 | 3 | 112 |
| 2016 | 3 | 99 |
| 2017 | 2 | 129 |
| 2018 | 1 | 29 |
| 2019 | 1 | 56 |
| 2020 | 2 | 64 |
| 2021 | 1 | 113 |
| 2022 | 4 | 110 |
| 2023 | 1 | 21 |
| 2024 | 4 | 85 |
| 2025 | 2 | 56 |
| 2026 | 1 | 110 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name SI-BONE, Inc. took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | 27 | 27 |
| OLO | Orthopedic Stereotaxic Instrument | 4 | 4 |
| PDQ | Neurosurgical Nerve Locator | 1 | 1 |
Review panels
- Orthopedic (31)
- Neurology (1)
Most recent SI-BONE, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253488 | iFuse INTRA Ti Implant System | OUR | 2026-02-11 | 110 |
| K253094 | iFuse Bedrock Granite Implant System | OUR | 2025-10-09 | 16 |
| K251780 | iGPS Navigation Instruments | OLO | 2025-09-15 | 97 |
| K241504 | iFuse TORQ TNT Implant System | OUR | 2024-08-19 | 83 |
| K241574 | iFuse TORQ® Implant System | OUR | 2024-07-02 | 29 |
| K232800 | Navigation Tracking Instruments | OLO | 2024-02-23 | 164 |
| K233508 | iFuse Bedrock Granite® Implant System | OUR | 2024-01-26 | 87 |
| K231689 | iFuse TORQ® Implant System | OUR | 2023-06-30 | 21 |
| K222774 | iFuse Bedrock Granite® Implant System | OUR | 2022-12-22 | 99 |
| K222605 | iFuse TORQ® Implant System | OUR | 2022-09-29 | 31 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named SI-BONE, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named SI-BONE, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05640908: Pelvic Fixation and Fusion During Multilevel Spinal Surgery (Active not recruiting, started 2023-06-05)
- NCT05870488: iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (Active not recruiting, started 2023-05-23)
- NCT04062630: SI Joint Stabilization in Long Fusion to the Pelvis (Completed, started 2020-05-20)
- NCT03122899: Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants (Completed, started 2017-10-03)
- NCT01741025: iFuse Implant System® Minimally Invasive Arthrodesis (Completed, started 2013-06)
SEC filings
SI-BONE, Inc. (SIBN): EDGAR filings, CIK 1459839. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under SI-BONE, Inc.?
FDA lists 32 510(k) clearances under the applicant name “SI-BONE, Inc.” (first 2008, latest 2026), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by SI-BONE, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name SI-BONE, Inc. is 96 days. Since 2017: 96 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under SI-BONE, Inc.?
The most frequent FDA product codes under this applicant name are OUR (Sacroiliac Joint Fixation, 27); OLO (Orthopedic Stereotaxic Instrument, 4); PDQ (Neurosurgical Nerve Locator, 1).
Next steps
- See all 32 SI-BONE, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OUR, SI-BONE, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.