ANTHEM® Fracture System

The ANTHEM® Fracture System is a family of bone fixation plates, screws, and washers used for internal fixation of fractures, osteotomies, arthrodesis, and bone reconstruction. The device is indicated for use in adult and pediatric patients across multiple anatomical sites including the humerus, radius, ulna, femur, tibia, and other bones. Specific plate types (distal humerus, proximal ulna, proximal radius) are designed for complex fracture patterns including comminuted, intra-articular, and periprosthetic fractures, as well as non-unions and malunions.

The subject ANTHEM® implants are manufactured from titanium alloy (ASTM F136), stainless steel (ASTM F138/F139), or additively manufactured titanium alloy powder (ASTM F3001). They have similar design, intended use, material composition, function, and size range as the predicate devices. The only technological difference is the manufacturing method for additively manufactured plates, which is identical to the reference device and does not raise new safety or effectiveness concerns.

Mechanical testing was conducted using static and dynamic four-point bending in accordance with ASTM F382 to demonstrate substantial equivalence. Biocompatibility was demonstrated through materials meeting applicable standards or used in other 510(k)-cleared devices.

The subject device shares identical technological characteristics, intended use, material composition, function, and size range with the predicate ANTHEM® Fracture System devices. The only difference—additive manufacturing for some plates—uses the same manufacturing method as the reference device and poses no new safety concerns. Mechanical testing per ASTM F382 and biocompatibility assessment confirm performance equivalence to legally marketed predicates.