# K092493: GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Gpc Medical, Ltd.
- Decided: Mar 29, 2010 after 227 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: 3 generations back to K983495 (1998). 4 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072562: Microware Bone Plates and Bone Screws, Microware Precision Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K110086: Ifs Profile Plates, Screws, and Washers (2011), 5 descendants of its own
- K161894: SurgTech Trauma System (2017), 3 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K143023: Nitinol Compression Plating System (2015), 2 descendants of its own
- K130614: Bone Fragment and Fixation Plates, Screws and Washers (2014), 2 descendants of its own

## Indications for use
GPC BONE PLATES AND BONE SCREWS ARE PROVIDED NON-STERILE. GPC BONE PLATES AND SCREWS ARE INTENDED TO TREAT FRACTURES OF VARIOUS BONES, INCLUDING THE CLAVICLE, PELVIS, SCAPULA, LONG BONES(HUMERUS, RADIUS, ULNA, FEMUR, TIBIA AND FIBULA), AND SMALL BONES-LIKE METALCARPALS, METATARSALS AND PHALANGES. GPC DHS/DCS PLATE SYSTEM IS PROVIDED NON-STERILE. THE GPC DHS/DCS PLAT SYSTEM IS INTENDED FOR USE IN FIXATION OF FRACTURES OF THE PROXIMAL FEMUR. THE GPC DHS/DCS PLATE SYSTEM IS INDICATED FOR USE IN TROCHANTERIC, PERTROCHANTERIC, INTERTROCHANTERIC AND BASILAR NECK FRACTURE

Source page: https://510kreport.com/device/K092493
Methodology: https://510kreport.com/methodology