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global resurfacing unicompartmental gru knee
Global Orthopaedic Technology, U
Summary: The Global Resurfacing Unicompartmental GRU Knee is a medical device used for partial knee resurfacing, primarily in orthopedic surgery. It is designed for use by orthopedic surgeons in patients requiring unicompartmental knee replacement.
FDA Clearance Information
Pathway
510K
Number
K033351 ↗
Decision Date
March 11, 2004
Product Code
HRY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on March 11, 2004. Manufactured by Global Orthopaedic Technology, it is classified as a Class II device under product code HRY.
What It Is
The Global Resurfacing Unicompartmental GRU Knee is a specialized implant designed for partial knee resurfacing. It targets the unicompartmental area of the knee, allowing for preservation of healthy bone and tissue. The device is typically made from biocompatible materials that integrate with the patient's anatomy, providing stability and improved joint function.
Clinical Applications
This device is commonly used in orthopedic surgical settings, particularly for patients with localized osteoarthritis or damage confined to one compartment of the knee. It is suitable for patients who are not candidates for total knee replacement but require intervention to alleviate pain and restore mobility. Orthopedic surgeons use this device in both hospital and outpatient surgical centers.
Indications for Use
The device is indicated for patients with knee joint degeneration limited to one compartment, often due to osteoarthritis or post-traumatic arthritis. It is suitable for patients who have not responded to conservative treatments and require surgical intervention.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies, ensuring a proper fit. Surgeons should consider the patient's bone quality and alignment during implantation. Compatibility with existing surgical instruments and techniques is typically straightforward, but training on the specific device may be beneficial.
Frequently Asked Questions
What is the Global Resurfacing Unicompartmental GRU Knee used for?
It is used for partial knee resurfacing in patients with unicompartmental knee damage, often due to osteoarthritis.
What specialties typically use this device?
Orthopedic surgeons specializing in knee surgeries and joint replacements typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with knee joint degeneration confined to a single compartment, such as from osteoarthritis or post-traumatic arthritis.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.