# K203811: GPC Intraheal Intramedullary Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Gpc Medical Limited
- Decided: Feb 10, 2022 after 409 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: 3 generations back to K013468 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040336: Synthes (Usa) Lateral Entry Femoral Nail System, Synthes (Usa) (2004) Summary page 7.
- K143245: GPC Intramedullary Nailing Systems, Gpc Medical Limited (2015) Summary page 7.
- K011857: Synthes (Usa) Trochanteric Fixation Nail (TFN) System, Synthes (Usa) (2001) Summary page 7.
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 8.
- K971783: Synthes Elastic Intramedullary Nail (Ein) System, Synthes (Usa) (1997) Summary page 8.
- K053105: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Synthes (Usa) (2005) Summary page 8.
- K100736: Kirschner and Guide Wires, Smt Schilling Metalltechnik GmbH (2010) Summary page 8.

## Indications for use
GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below: Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below: - To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions. Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below: Short Nail Indications: - . Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion . and tumor resections Long Nail Indications: - . Indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures. Elastic Nails: The Elastic Nail is indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients. In paediatric application, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate. K-Wires: K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system All implants are for single use only.

Source page: https://510kreport.com/device/K203811
Methodology: https://510kreport.com/methodology