# K163361: ANTHEM™ Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Apr 7, 2017 after 128 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: 12 generations back to K962616 (1996). 229 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 244 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073460: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 4.
- K112437: Arthrex Fracture System, Arthrex, Inc. (2011) Summary page 4.
- K092556: Synthes (Usa) 2.4MM VA-LCP Two-Column Narrow Volar Distal Radius, Synthes (Usa) (2009) Summary page 4.
- K982732: Synthes (Usa) Distal Radius Plate System (DRPS), Synthes (1998) Summary page 4.
- K133974: Variax Distal Radius Plating System, Stryker Leibinger GmbH (2014) Summary page 4.
- K111620: Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right, Standard 3 Hole Left, Skeletal Dynamics, Skeletal Dynamics, LLC (2011) Summary page 4.
- K040112: Trimed Bearing Plate; Trimed Volar Bearing Plate, Tri-Med, Inc. (2004) Summary page 4.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 4.
- K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates, Synthes (Usa) (2010) Summary page 4.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 4.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 4.
- K041965: Arthrex Humeral Fracture Plates and Screws, Arthrex, Inc. (2004) Summary page 4.
- K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates, Synthes (Usa) (2008) Summary page 4.
- K143697: Biomet Proximal Humerus Plating System, Biomet Manufacturing (2015) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K060514: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 4.
- K083032: Peri-Loc Bone Plating and Screw System, Smith & Nephew, Inc. (2009) Summary page 4.
- K083286: Orthopediatrics Pediloc Locking Plate System, OrthoPediatrics Corp. (2009) Summary page 4.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 4.
- K153716: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System., Gpc Medical, Ltd. (2016) Summary page 4.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K140814: Evos Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 5.
- K951303: SFC, Medpac (1995) Summary page 5.
- K133668: Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate, Right, Aft Greater Tuberosity Cannul, Shoulder Options, Inc. (2014) Summary page 5.
- K060290: Shoulder Fixation System, Hand Innovations, LLC (2006) Summary page 5.
- K070946: Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates, Synthes (Usa) (2007) Summary page 5.

## Most influential descendants
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- 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

## 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. Small fragment 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).

Source page: https://510kreport.com/device/K163361
Methodology: https://510kreport.com/methodology