LORRAINE 2.5/3.5mm Distal Humerus System

The LORRAINE 2.5/3.5mm Distal Humerus System is a bone fixation device consisting of metallic plates and screws used to treat fractures of the distal humerus, including intra-articular, extra-articular, supracondylar fractures, osteotomies, and non-unions. The plates are made from stainless steel with titanium inlay clips, and screws are stainless steel, designed to provide rigid fixation for bone healing.

The subject device and predicate devices share identical intended use, similar indications, fabrication from the same materials (stainless steel and titanium), and same design characteristics including plate screw holes for locking and non-locking screws. Both encompass the same range of physical dimensions, and the subject device is compatible with screws from the primary predicate device, using standard sterilization methods.

ISO 5832-1, ASTM F138, ASTM F139 (stainless steel); ASTM F67, ISO 5832-2 (titanium); ISO 11137-2 (sterilization); ISO 17664, ISO 17665-1 (steam sterilization); ISO 11607, ASTM F1980 (packaging); ISO 10993-series (biocompatibility); ASTM F2052-21, ASTM F2213-17, ASTM F2182-19, ASTM F2119-24 (MRI safety).

Static and dynamic mechanical testing demonstrated that the subject plate variants achieve substantially equivalent maximum force, yield strength, construct stiffness, and cyclic performance compared to their respective predicate devices, with all predefined acceptance criteria met. The subject device maintains identical material composition, design architecture, and screw compatibility with the primary predicate, and non-clinical biocompatibility and sterilization validation confirm safe biological performance equivalent to the predicate.