TiLink-P SI Joint Fusion System

The TiLink-P SI Joint Fusion System is a titanium sacroiliac joint implant with associated surgical instruments designed to fuse the sacroiliac joint. It is intended for sacroiliac joint fusion to treat sacroiliac joint disruptions and degenerative sacroiliitis, and can be implanted via lateral or posterior oblique approach with bone graft material.

The device is made of titanium and consists of implants and associated sterile or non-sterile surgical instruments. It has the same intended use, technological characteristics, and materials as the predicate devices (TiLink-P and TiLink-L SI Joint Fusion Systems from SurGenTec, and the MSB Sacroiliac Joint Fusion Device from Medtronic).

Axial Pullout Testing per ASTM F543, Static and Dynamic Cantilever Test per ASTM F3574, Sterilization, Packaging, and Shelf-Life Validations, and Biocompatibility Assessment per ISO 10993.

The TiLink-P is substantially equivalent because the subject device and predicate devices share identical intended use (sacroiliac joint fusion for the same clinical conditions), the same titanium materials, and the same technological approach of titanium implants with surgical instruments. Performance testing demonstrates the device performs as well as or better than predicates across mechanical strength, sterilization, and biocompatibility measures.