# K212433: Anthem Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Oct 1, 2021 after 58 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K962616 (1996). 289 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 297 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180554: ANTHEM Fracture System, Globus Medical, Inc. (2018) Summary page 4.
- K202496: ANTHEM Fracture System, Globus Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K213591: ANTHEM® Fracture System (2022), 5 descendants of its own
- K232652: Anatomical Plating System (various) (2023), 3 descendants of its own
- K241218: Tyber Medical Anatomical Plating System (2024), 2 descendants of its own
- K242486: Tyber Medical Anatomical Plating System (2025), 1 descendant of its own
- K261207: Exalta Proximal Tibia Plating System (2026), 0 descendants of its own

## Indications for use
The ANTHEM® Fracture System is indicated for fixation of fractures, osteotomies, 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, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization and reduction of long bone fragments, and for fixation of bones including the radius and ulna. In addition, small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adults. 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.

Source page: https://510kreport.com/device/K212433
Methodology: https://510kreport.com/methodology