| K-number | K250247 |
| Device name | panaSIa SI Fusion System |
| Applicant | Wenzel Spine, Inc. |
| Product code | OUR |
| Device class | Class II |
| Decision date | Jul 9, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The panaSIa SI Fusion System is a threaded, expandable titanium implant designed to stabilize the sacroiliac joint for patients with sacroiliac joint disruptions and degenerative sacroiliitis. The device pierces adjacent cortical bone when expanded and features large fenestrations to allow uninterrupted graft contact across the SI joint space.
The device is a threaded, expandable implant made of titanium grade alloy for long-term implantation. It has similar design, materials, principles of operation, and performance characteristics to the predicate devices (Camber SI Fixation System and Medtronic RIALTO SI Fusion System), which are also sacroiliac joint fusion devices with comparable technological features.
Static and dynamic vertical shear testing per ASTM F3574 and cadaver testing with comparison to the additional predicate device.
The subject device shares the same intended use (sacroiliac joint fusion for joint disruptions and degenerative sacroiliitis) and similar principles of operation and design as the predicates. Non-clinical testing data, including ASTM F3574 shear testing and cadaver testing, demonstrated that the panaSIa performs comparably to the predicate devices, supporting the conclusion that it is as safe, effective, and performs as well as or better than the predicates.
View the full FDA submission: accessdata.fda.gov