# K210198: GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive

- Pathway: 510(k) (Traditional)
- Applicant: Gpc Medical Limited
- Decided: Jan 7, 2022 after 347 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: 4 generations back to K962616 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092556: Synthes (Usa) 2.4MM VA-LCP Two-Column Narrow Volar Distal Radius, Synthes (Usa) (2009) Summary page 5.
- K110125: 2.4 MM VA-LCP Volar Rim Distal Radius System, Synthes USA (2011) Summary page 5.

## Indications for use
GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is provided non-sterile. GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The system is indicated for use in adult patients only. All implants are for single use only.

Source page: https://510kreport.com/device/K210198
Methodology: https://510kreport.com/methodology