Patriot-SI Posterior Implant System
FDA 510(k) K232259 · Spinal Simplicity, LLC
510(k) numberK232259
Submission
- Device name
- Patriot-SI Posterior Implant System
- Applicant
- Spinal Simplicity, LLC
Overland Park, KS, US - Received
- July 31, 2023
- Decision date
- April 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K253523 | Freedom DS Decompression SystemHRX · Traditional | 04/16/2026SE |
| K253250 | Minuteman® G6 MIS Fusion PlatePEK · Traditional | 12/01/2025SE |
| K250001 | Patriot SI Implant SystemOUR · Traditional | 06/03/2025SE |
| K240592 | Wolff's Law Anterior Cervical Plate SystemKWQ · Traditional | 05/24/2024SE |
| K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…PEK · Special | 01/18/2024SE |
| K231923 | Liberty SI Lateral Implant SystemOUR · Traditional | 12/05/2023SE |
| K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…PEK · Special | 11/29/2023SE |
| K221307 | Edge Upper Cervical SystemNKG · Traditional | 07/10/2023SE |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…PEK · Traditional | 08/19/2022SE |
| K211880 | Minuteman G5 MIS Fusion PlatePEK · Traditional | 03/11/2022SE |
Questions and answers
When was Patriot-SI Posterior Implant System cleared by the FDA?
Patriot-SI Posterior Implant System (K232259) received a 510(k) decision of Substantially Equivalent on April 19, 2024, 263 days after the submission was received.
What is the product code of K232259?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.