iFuse INTRA Ti™ Implant System

The iFuse INTRA Ti Implant System is a sterile, single-use implant made from titanium alloy (Ti-6Al-4V ELI) using additive manufacturing, designed to fuse the sacroiliac joint. It is indicated for sacroiliac joint dysfunction resulting from joint disruption and degenerative sacroiliitis, including conditions with symptoms beginning during pregnancy or the peripartum period that persist postpartum for more than 6 months.

The device is additively manufactured using Ti-6Al-4V ELI per ASTM F3001 with porous features designed to promote joint fusion. It includes single-use instruments for implant placement. The design incorporates technological changes compared to the predicate iFuse TORQ system, but maintains equivalent intended use, materials, manufacturing principles, and operational characteristics.

ASTM F3001 (titanium alloy specification), ASTM F3574 (mechanical testing including static shear, dynamic shear fatigue, and static torsion). ISO 13485 clauses 7.3 (design controls) and 8.5 (corrective and preventative action) are also referenced as applicable quality management system requirements.

The iFuse INTRA Ti is substantially equivalent to its predicates (Catamaran Sacroiliac Joint Fixation System, iFuse TORQ, DePuy Synthes cannulated screws, and iFuse 3D) because it shares the same intended use, indications for use, technological characteristics, materials, manufacturing methods, and principles of operation. Benchtop performance testing demonstrates substantially equivalent safety and effectiveness, and no new questions of safety and effectiveness are raised compared to predicate devices.