# K143245: GPC Intramedullary Nailing Systems

- Pathway: 510(k) (Traditional)
- Applicant: Gpc Medical Limited
- Decided: Sep 30, 2015 after 322 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972813 (1997). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040762: Synthes (Usa) Tibial Nail System EX, Synthes (Usa) (2004) Summary page 6.
- K972813: Gamma Locking Nail System, Howmedica Corp. (1997) Summary page 6.

## Most influential descendants
- K253517: Reselute Tibial Nail (2026), 0 descendants of its own
- K203811: GPC Intraheal Intramedullary Nailing System (2022), 0 descendants of its own

## Indications for use
1. Indication for Use: Multi Angle Tibial Nail : The multi angle tibial nail is intended to stabilize fracture of the proximal & distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions & nonunions. 2. Indications for Use: Ga-mma Nails: The Ga-mma Nail is indicated for use in stabilizing various types of intertrochanteric fractures of proximal femur.

Source page: https://510kreport.com/device/K143245
Methodology: https://510kreport.com/methodology