GPC Intraheal Intramedullary Nailing System

510(k) Number

K203811 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Kirschner Wire, Single Ended - S.S.

  Class IIb

  CE/MDD

• 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

  Class II

  FDA 510(k) K210198 Active Cleared 7 Jan 2022

• GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

  Class II

  FDA 510(k) K163096 Active Cleared 31 Mar 2017

• GPC Intramedullary Nailing Systems

  Class II

  FDA 510(k) K143245 Active Cleared 30 Sep 2015

• Straight Plate with Gap, 1.5/2.0 mm - 2 Holes

  Class IIb

  CE/MDR

• fixLOCK DHS Plate 4.5 mm - 125° - S.S.

  Class IIb

  CE/MDR

See all devices from GPC Medical Limited →

• What types of long bone fractures is the GPC Intraheal Intramedullary Nailing System specifically designed to stabilize, and how does it achieve this?

  The GPC Intraheal Intramedullary Nailing System is designed to stabilize fractures of long bones such as the femur or tibia. It achieves stable alignment and support through intramedullary placement of stainless steel or titanium nails, which are locked into place with screws. This internal fixation method helps reconstruct and stabilize the fractured bone, promoting proper bone union and functional recovery during the healing process.

• Is the GPC Intraheal Intramedullary Nailing System intended for reuse, or is it meant to be used only once per patient? Why does this matter?

  The GPC Intraheal Intramedullary Nailing System is supplied as a sterile, single-use orthopedic implant. This matters because single-use implants reduce the risk of cross-contamination and infection, ensuring patient safety and compliance with sterile surgical protocols. Reuse could compromise sterility and integrity, potentially leading to complications.

• What materials are the nails and screws in this system made from, and how does this affect their use in surgery?

  The nails and screws in the GPC Intraheal Intramedullary Nailing System are constructed from either stainless steel or titanium. These materials are chosen for their strength, biocompatibility, and resistance to corrosion, ensuring durability during surgery and compatibility with the body’s healing process. Titanium, in particular, is often preferred for its lighter weight and lower risk of allergic reactions.

• How should the system be stored before use, and why is this important for maintaining its effectiveness?

  The GPC Intraheal Intramedullary Nailing System must be stored following standard sterile orthopedic implant protocols to preserve its integrity and sterility. This includes keeping it in a sealed, sterile packaging until ready for surgical use. Proper storage prevents contamination, damage, or degradation of the implant’s properties, ensuring it remains safe and effective when used in the operating room.

• Are there different sizes or models available, and if so, how are they determined?

  Yes, the system includes multiple model numbers and sizes, differentiated by the specific anatomical site or fixation need (e.g., femur vs. tibia). These variations allow surgeons to select the appropriate nail and screw configuration for optimal stabilization, ensuring a precise fit and effective treatment tailored to the patient’s fracture.