Integrity-SI Fusion System
FDA 510(k) K222512 · OsteoCentric Technologies
510(k) numberK222512
Submission
- Device name
- Integrity-SI Fusion System
- Applicant
- OsteoCentric Technologies
Logan, UT, US - Received
- August 19, 2022
- Decision date
- September 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUR – Sacroiliac Joint Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
sacroiliac joint fusion
Other 510(k)s with product code OUR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | SurGenTec, LLC | 08/24/2026SE |
| K260477 | CATAMARAN SI Joint Fusion SystemOUR · Traditional | Tenon Medical | 04/08/2026SE |
| K253488 | iFuse INTRA Ti Implant SystemOUR · Traditional | SI-BONE, Inc. | 02/11/2026SE |
| K253611 | Falco Fusion SystemOUR · Traditional | Mcnicoll Surgical, Inc. | 01/29/2026SE |
| K252834 | Sacroiliac Joint Truss System (SJTS)OUR · Traditional | 4Web Medical | 01/28/2026SE |
| K251365 | OptumSI Implant SystemOUR · Traditional | Si Solutions, LLC | 11/20/2025SE |
| K252322 | SIros-X SystemOUR · Traditional | Genesys Spine | 10/22/2025SE |
| K253094 | iFuse Bedrock Granite Implant SystemOUR · Special | SI-BONE, Inc. | 10/09/2025SE |
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | Eminent Spine | 10/07/2025SE |
| K250647 | SImmetry+ SystemOUR · Traditional | Sivantage | 07/29/2025SE |
More from Sivantage
| 510(k) | Device | Decision |
|---|---|---|
| K250520 | OsteoCentric Navigated Instruments SystemOLO · Traditional | 10/27/2025SE |
| K251913 | OsteoCentric® UnifiMI® TCS Plating SystemHRS · Special | 08/16/2025SE |
| K250494 | The OsteoCentric Bone Plate and Screw SystemHRS · Special | 03/18/2025SE |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and NutsHWC · Special | 10/09/2024SE |
| K230242 | OsteoCentric Dental Implant SystemDZE · Traditional | 10/05/2023SE |
| K230226 | Integrity-SI® Fusion SystemOUR · Special | 09/21/2023SE |
| K230595 | OsteoCentric ACL Fixation SystemHWC · Traditional | 06/29/2023SE |
| K230764 | OsteoCentric Integrated Hip Fastener SystemJDO · Special | 04/18/2023SE |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener SystemNKB · Traditional | 07/28/2022SE |
| K211290 | Cannulated Fasteners and NutsHWC · Special | 08/03/2021SE |
Questions and answers
When was Integrity-SI Fusion System cleared by the FDA?
Integrity-SI Fusion System (K222512) received a 510(k) decision of Substantially Equivalent on September 12, 2022, 24 days after the submission was received.
What is the product code of K222512?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.