GMReis Fibula Nail System

The GMReis Fibula Nail System is a locked intramedullary nail system designed for surgical fixation of fibular fractures and osteotomies. It features multiple lengths (110–180 mm) and diameters (3.0 and 3.6 mm), manufactured from titanium alloy, supplied non-sterile, and intended for single use.

The subject device differs from the predicate primarily in nail length and diameter options; the predicate offers longer nails and both smaller and larger diameter variants, plus stainless steel options, whereas the subject device is titanium-only. Both use identical materials, manufacturing processes, and facilities for final components, with the same basic locked intramedullary design and screw profile to reduce skin prominence.

ASTM F1264 and ASTM F543 were used for mechanical testing to demonstrate performance equivalence to the predicate device.

The subject and predicate devices share the same fundamental design, intended use, materials, sterilization methods, and manufacturing processes. Minor dimensional variations (nail length and diameter ranges) and the elimination of stainless steel options do not raise different safety or effectiveness questions, as the subject device's performance is equivalent per mechanical testing. The core locking mechanism, screw profile, and clinical application remain unchanged.