RIB LINK™ Fixation System

The RIB LINK™ Fixation System is a bone fixation device consisting of plates, rods, and screws made from titanium alloy, designed to stabilize and reconstruct rib fractures, fusions, osteotomies, resections, gaps, defects, and chest wall deformities including rib hump deformity in skeletally mature patients with normal or osteoporotic bone.

The subject device has similar technological characteristics to the predicate devices including design, intended use, material composition (titanium alloy per ASTM F136), function, and range of sizes. It includes rods that connect different plate types along the ribs for posterior thorax use, and when spanning gaps, some devices permit 4 cortices of fixation at each end, equal to or less than the predicate devices.

Performance testing was conducted using ASTM F1717 (with modifications for rib fixation applications) for static and fatigue evaluation of constructs, and ASTM F543 for screw testing.

The RIB LINK™ system is substantially equivalent to predicate devices (primarily Depuy Synthes MatrixRIB) because it demonstrates similar technological characteristics, performance data, and intended use. Although it adds a rib hump deformity indication, posterior thorax reconstruction presents risks similar to lateral and anterior thorax procedures already covered by the predicate, supporting substantial equivalence.