OsteoCentric® UnifiMI® TCS Plating System

The OsteoCentric® UnifiMI® TCS Plating System is a bone fixation device consisting of metallic plates and screws used to treat fractures, osteotomies, and non-unions across multiple skeletal sites including the clavicle, humerus, radius, ulna, tibia, and fibula. The system includes both locking and non-locking plate and screw combinations, along with instruments for implant installation and removal.

The device introduces 2.7mm angle iron plates fabricated from either medical-grade stainless steel (ASTM F138) or titanium (ASTM F136), with additional screw sizes compared to the predicate. The principal advancement is that the new plate geometry provides stronger and more stable fixation in a smaller form factor, reducing surgical incision size and soft tissue disruption while maintaining equivalent mechanical performance to larger predicate plates.

ASTM F138 (medical-grade stainless steel), ASTM F136 (titanium). Non-clinical engineering analysis was performed to demonstrate the new plates and screws do not present a new worst-case design.

The device shares identical indications for use, principle of operation, and product codes (HRS, HWC) with three predicate devices. Engineering analysis confirmed that mechanical strength, sterility, bone plate sizes, and screw sizes are equivalent to the predicates despite the new 2.7mm angle iron geometry. The technological change—stronger plate in smaller form factor—represents an optimization of existing design rather than a fundamental departure, with the same clinical functionality and material composition meeting established standards.