Engineer Aid was contracted by SI Solutions to provide full product development of a sacroiliac joint fusion system, including the implants and instrumentation required to perform the complete surgical procedure.

The implant was specifically designed for titanium alloy additive manufacturing, incorporating multiple lattice structures engineered to support both bone in-growth and on-growth. Its innovative cross-sectional profile was developed to provide high levels of joint stabilization while maximizing surface contact, creating an optimized interface for osseointegration.

Engineer Aid led the project from initial planning and concept development through design, manufacturing, verification and validation, and regulatory submission. Our scope included development and maintenance of the Quality Management System and Design History File, as well as the complete suite of design outputs, including:

• Sacroiliac fusion implants
• Surgical instrumentation
• Steam sterilization trays
• Sterile packaging
• Product labeling and associated documentation
• Manufacturing process definition and design transfer materials

Drawing on extensive experience in spine implant development and medical device engineering, Engineer Aid also managed the technical and regulatory activities required to bring the system to market, culminating in successful FDA 510(k) clearance.

The result was a complete, manufacturable sacroiliac fusion system that met the project’s technical and clinical objectives and exceeded the client’s expectations.