Genostis Osteosynthesis System

The Genostis Osteosynthesis System is a fracture fixation device comprising metallic plates and screws made of titanium alloy (Ti 6Al 4V ELI) used for temporary fixation, correction, or stabilization of bones in various anatomical regions. The system includes multiple plate designs (one-quarter tubular, straight, reconstruction, buttress, and specialty plates) and corresponding locking and non-locking screws for different fracture types throughout the foot, hand, wrist, forearm, elbow, and leg.

The Subject and predicate devices share identical technological characteristics: same designs, materials (titanium alloy per ASTM F136 and ISO 5832-3), chemical composition, and principle of operation. Both feature similar plate and screw interface options (locking, non-locking, or combination). The devices are manufactured to equivalent specifications and sterilized by radiation.

ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-23 (Irritation/Intracutaneous Reactivity), ISO 10993-18 (Chemical Characterization), ASTM F136 (Titanium Alloy), ISO 5832-3 (Titanium Alloy), ASTM F543 (Screw Performance), ASTM F382 (Plate Performance). Bacterial endotoxin testing and biocompatibility risk assessment were also performed.

The indications for use between the Subject device and predicates are identical with only minor wording differences. Both the Subject and predicate devices possess the same technological characteristics, including identical designs, materials, chemical composition, and operating principles. Comprehensive biomechanical and biocompatibility testing demonstrated that the Subject device is substantially equivalent to the predicates. All testing results were satisfactory and met applicable ISO and ASTM standards, confirming equivalence across mechanical performance and biocompatibility domains.