iFuse Bedrock Granite Implant System

The iFuse Bedrock Granite Implant System is a titanium spinal implant designed for sacroiliac joint fusion in skeletally mature patients. It consists of a porous fusion sleeve with threaded length attached to a solid post compatible with standard pedicle screw systems, intended to stabilize the sacroiliac joint and spine in patients with degenerative joint disease, trauma, deformities, and related conditions.

The device is made of titanium (Ti-6Al-4V ELI) with a porous fusion sleeve and threaded section. The primary change in this submission is the addition of an alternative set screw option called the Granite Point Lock Set Screw. The implant connects to commercially available pedicle screw systems via 5.5 mm or 6.0 mm titanium alloy or cobalt chrome rods.

Axial gripping capacity per ASTM F1798 (Static axial slip), Torsional gripping capacity per ASTM F1798 (Static axial torsion), and Dynamic axial compression per ASTM F1717 (Dynamic compression bending).

The subject device is substantially equivalent to its predicate devices in intended use, technological characteristics, principles of operation, materials, manufacturing, labeling, sterility, and non-clinical mechanical performance. Mechanical testing demonstrates performance comparable to the predicate device, and the alternative set screw component does not alter the fundamental function or safety profile.