GPC Intramedullary Nailing Systems
by GPC Medical Limited India 510(k)
510(k) K143245
Product code HSB
Overview
The GPC Intramedullary Nailing Systems are orthopedic devices designed for the internal fixation of long bone fractures, including femur and tibia. These systems utilize intramedullary nails to stabilize and align fractured bones, promoting proper healing through rigid internal support. The nails are inserted into the medullary cavity of the bone, providing structural integrity during the recovery process.
These systems are supplied as sterile, single-use devices and are intended for use in orthopedic surgical settings. The intramedullary nails are available in various sizes and lengths to accommodate different patient anatomies. The device holds FDA 510(k) clearance under the traditional review pathway, with a classification under the Orthopedic advisory committee. Sterility and regulatory compliance are ensured through manufacturer-controlled processes, adhering to global medical device standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143245 | Date30 Sep 2015 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HSB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
GPC Medical - India's largest manufacturer and supplier of intramedullary nail instruments. We offer superior quality intramedullary naliing instruments at highly competitive prices. Get free catalog and best price quotes instantly.
Most of our Orthopaedic Implants including spinal system, intramedullary interlocking nail, locking/non-locking bone plates & screws are US FDA 510 (K) approved.
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Questions
What types of long bone fractures are the GPC Intramedullary Nailing Systems specifically designed to treat?
The GPC Intramedullary Nailing Systems are designed for internal fixation of fractures in long bones, specifically the femur and tibia. The intramedullary nails provide rigid internal support to stabilize and align these bones, aiding proper healing during recovery.
Are the GPC Intramedullary Nailing Systems reusable or intended for single-use only?
The GPC Intramedullary Nailing Systems are supplied as sterile, single-use devices. This ensures patient safety and compliance with medical device standards, as reuse is not recommended or supported by the manufacturer.
How are the nails sized and what determines the appropriate size for a patient?
The GPC Intramedullary Nailing Systems come in various sizes and lengths to accommodate different patient anatomies. The correct size is determined by the surgeon based on the patient’s bone dimensions and fracture characteristics, ensuring proper alignment and stability during healing.
What regulatory pathway was followed for FDA clearance of the GPC Intramedullary Nailing Systems?
The GPC Intramedullary Nailing Systems received FDA clearance under the traditional review pathway, classified under the Orthopedic advisory committee (OR). The clearance was granted as substantially equivalent (SESE) to a predicate device, ensuring compliance with U.S. medical device regulations.
How should the GPC Intramedullary Nailing Systems be stored to maintain sterility?
Since these systems are sterile, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for proper handling to preserve sterility until use.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K143245