# K153716: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.

- Pathway: 510(k) (Traditional)
- Applicant: Gpc Medical, Ltd.
- Decided: May 17, 2016 after 145 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: 5 generations back to K962616 (1996). 53 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 7.
- K051986: Synthes 4.5 MM LCP Straight Reconstruction Plates, Synthes (Usa) (2005) Summary page 7.
- K030858: Synthes (Usa) LCP Proximal Femur Plate and Screws, Synthes (Usa) (2003) Summary page 7.
- K023802: Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System, Synthes (Usa) (2003) Summary page 7.
- K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 7.
- K983787: Synthes Proximal Tibia Plating System, Synthes (Usa) (1999) Summary page 7.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 7.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 7.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 7.
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates, Synthes (Usa) (2010) Summary page 8.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 8.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 8.
- K062494: Ebi Optilock Upper Extremity Plating System, Ebi, L.P. (2006) Summary page 8.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 8.
- K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 8.
- K982732: Synthes (Usa) Distal Radius Plate System (DRPS), Synthes (1998) Summary page 8.
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 8.
- K040777: LCP Radial Head Plating System, Synthes (Usa) (2004) Summary page 8.
- K033975: Synthes 2.4 MM Titanium (TI.) Locking Screws, Synthes (Usa) (2004) Summary page 8.
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 8.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 9.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 9.

## Most influential descendants
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- 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

## Indications for use
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are provided non-sterile. GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). The system is indicated for use in adult patients only. All implants are for single use only.

Source page: https://510kreport.com/device/K153716
Methodology: https://510kreport.com/methodology