# K173166: ANTHEM Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Nov 13, 2017 after 45 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: 13 generations back to K962616 (1996). 257 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 269 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163361: ANTHEM™ Fracture System, Globus Medical, Inc. (2017) Summary page 4.
- K101536: 2.7/3.5MM VA-LCP Anteriro Clavicle Plate System, Synthes (Usa), LLC (2010) Summary page 4.
- K111540: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2011) Summary page 4.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 4.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 4.
- K130116: Superior Lateral Variax Clavicle Plate, Stryker Trauma AG (2013) Summary page 4.
- K140259: Variax Clavicle Hook Plate, Stryker Trauma AG (2014) Summary page 4.
- K083286: Orthopediatrics Pediloc Locking Plate System, OrthoPediatrics Corp. (2009) Summary page 4.
- K071563: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2007) Summary page 4.
- K092015: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2009) Summary page 4.
- K133440: Axsos 3 TI Locking Plate System Line Extension, Stryker Trauma AG (2013) Summary page 4.

## Most influential descendants
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own
- K212433: Anthem Fracture System (2021), 7 descendants of its own
- K213591: ANTHEM® Fracture System (2022), 5 descendants of its own
- K232652: Anatomical Plating System (various) (2023), 3 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. Small fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.

Source page: https://510kreport.com/device/K173166
Methodology: https://510kreport.com/methodology