BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System

The BRUSIO Trauma Toolbox System and TAMINA 3.5mm Proximal Humerus System are metallic bone fixation devices used for internal fixation of fractures, osteotomies, and nonunions. The BRUSIO system treats fractures of the appendicular skeleton (clavicle, scapula, humerus, olecranon, pelvis, femur, tibia, fibula) with non-load-bearing stabilization. The TAMINA system specifically treats proximal humerus fractures, non-unions, and osteotomies, including those with osteopenic bone.

Both devices consist of stainless steel plates (ISO 5832-1, ASTM F138/F139) with Titanium Inlay Clips made of pure titanium (ASTM F67), and stainless steel locking and non-locking screws. The subject and predicate devices share identical materials, design characteristics including screw hole accommodation for both locking and non-locking screws, comparable physical dimensions, and cross-compatibility with predicate device screws. All are sterilized by gamma irradiation or steam sterilization and are MR Conditional.

ISO 11137-2 (sterilization), ISO 17664 and ISO 17665-1 (steam sterilization validation), ISO 11607 (packaging), ASTM F1980 (packaging), ISTA 2A (transport simulation), ISO 10993-series (biocompatibility), ASTM F2052-21 and F2213-17 (MRI displacement/torque), ASTM F2182-19 (MRI heating), and ASTM F2119-24 (MRI artifacts).

The subject devices have the same intended use, similar indications for use, and identical technological characteristics and materials as their respective predicate devices. Non-clinical testing including static/dynamic mechanical testing, biocompatibility, sterilization validation, and MRI safety testing demonstrated substantial equivalence to predicate devices. All predefined acceptance criteria were successfully met for mechanical performance, confirming the subject devices are substantially equivalent to the predicates.