Spinal Simplicity, LLC · Class II · Cleared Jun 3, 2025
| K-number | K250001 |
| Device name | Patriot SI Implant System |
| Applicant | Spinal Simplicity, LLC |
| Product code | OUR |
| Device class | Class II |
| Decision date | Jun 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Patriot SI Implant System is a minimally invasive sacroiliac joint fusion implant made from titanium alloy that is placed across the sacroiliac joint to stabilize and fuse it. It is intended for sacroiliac joint fusion in patients with sacroiliac joint disruptions and degenerative sacroiliitis, and may be used with bone graft materials.
The device is manufactured from commercially pure titanium alloy (Ti-6Al-4V-ELI) per ASTM F3001 and may optionally include a hydroxyapatite (HA) coating per ASTM F1185. It is available in one size and is provided sterile and individually packed. There have been no significant changes to the technological characteristics since the previous submission.
Non-clinical cadaveric biomechanical testing was performed. The document references ASTM F3001 for titanium alloy material specifications and ASTM F1185 for hydroxyapatite coating specifications.
The device is substantially equivalent to the Patriot-SI Posterior Implant System (K232259) predicate device based on non-clinical cadaveric biomechanical testing demonstrating that the Patriot SI Implant System performs as intended and is as safe and effective as the predicate device for the stated sacroiliac joint fusion indications. The device shares the same intended use, materials (titanium with optional HA coating), and operational principles as the predicate.
View the full FDA submission: accessdata.fda.gov