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global resurfacing unicompartmental knee system
Global Orthopaedic Technology, U
Summary: The Global Resurfacing Unicompartmental Knee System is a medical device used for partial knee replacement, specifically targeting one compartment of the knee. It is primarily used by orthopedic surgeons in cases where only part of the knee is affected by arthritis.
FDA Clearance Information
Pathway
510K
Number
K051721 ↗
Decision Date
October 26, 2005
Product Code
HRY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on October 26, 2005. It is manufactured by Global Orthopaedic Technology and classified as a Class 2 device under product code HRY.
What It Is
The Global Resurfacing Unicompartmental Knee System is designed for unicompartmental knee arthroplasty, a procedure that replaces only the damaged compartment of the knee joint. This system allows for a less invasive approach compared to total knee replacement, preserving more of the patient's natural knee structure. It typically involves resurfacing the affected area with metal and polyethylene components to restore joint function and alleviate pain.
Clinical Applications
This device is commonly used in orthopedic surgical settings, particularly for patients with osteoarthritis confined to a single compartment of the knee. It is suitable for patients who have not responded to conservative treatments and are not yet candidates for total knee replacement. The procedure is often performed in hospitals or specialized orthopedic centers, and the patient population includes adults, typically over the age of 50, who maintain an active lifestyle.
Indications for Use
The FDA indications suggest that this device is intended for patients with unicompartmental knee arthritis, where only one part of the knee is affected. It is suitable for those who have not found relief from non-surgical treatments and require surgical intervention to improve mobility and reduce pain.
Practical Considerations
The system is available in various sizes to accommodate different patient anatomies, ensuring a proper fit and optimal function. Surgeons should be familiar with the specific surgical techniques associated with unicompartmental knee arthroplasty, including precise alignment and fixation of the components. Compatibility with existing surgical instruments and techniques is generally considered during the planning phase.
Related Literature
The linked study compared medial unicondylar knee arthroplasty with total knee arthroplasty. Although the abstract is not available, such studies typically focus on outcomes like pain relief, joint function, and recovery time. Key findings often highlight the benefits of a less invasive procedure with quicker recovery, but limitations may include a lack of long-term data or a small sample size.
Frequently Asked Questions
What is the Global Resurfacing Unicompartmental Knee System used for?
It is used for partial knee replacement in patients with arthritis affecting only one compartment of the knee.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and knee surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients with unicompartmental knee arthritis who require surgical intervention after non-surgical treatments have failed.
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.