(75 days)
The ANTHEM® Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur plates are indicated for diaphyseal, metaphyseal, epiphyseal, supracondylar, intra-articular, condylar, periprosthetic, and comminuted fractures, and for non-unions, Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantations and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization of long bone fragments, and for fixation of bones including the radius and ulna.
In addition to adult patients, small fragment, proximal tibia, clavicle, metaphyseal, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature plates are indicated for use in the diaphyseal areas of long bones in adolescent pediatric patients. Distal radius. distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can be used in patients with osteopenic bone.
The ANTHEM® Fracture System is a family of plates, screws, and washers designed to be used for internal bone fixation. The ANTHEM® Distal Femur implants are designed for fractures of the distal femur, and are available in various sizes and configurations to accommodate patient anatomy. The ANTHEM® implants are manufactured from titanium, titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537, F2229, F138 and F139.
This is a 510(k) premarket notification for a medical device called the ANTHEM® Fracture System, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not applicable.
The 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance based on clinical outcomes or AI model metrics. The performance data provided are limited to engineering analysis and material testing, which are standard for orthopedic hardware submissions.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.