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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 ?
510(k)
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.
FDA-Cleared Indications
- Unicompartmental knee arthroplasty for degenerative arthritis confined to one compartment of the knee.
- Replacement or resurfacing of the affected knee compartment in patients requiring surgical treatment after inadequate relief from conservative care.
Clinical Applications
- Partial knee replacement for unicompartmental osteoarthritis.
- Resurfacing of the damaged medial or lateral knee compartment.
- Treatment of pain and loss of function caused by arthritis limited to one knee compartment.
- Use in adults selected for unicompartmental knee arthroplasty based on clinical examination and imaging.
Practical Considerations
- The system is available in multiple component sizes; the surgeon selects sizes based on the patient's anatomy and intraoperative fit.
- The procedure requires accurate bone preparation, alignment, sizing and fixation using the system's compatible instruments and surgical technique.
- This is a knee implant, not an intravascular device. MRI safety should be confirmed from the current manufacturer labeling and implant documentation before scanning.
- Patient selection is important. Advanced disease in multiple knee compartments, infection, inadequate bone stock, ligament instability or other contraindications may make unicompartmental replacement inappropriate.
- Expected durability depends on implant positioning, activity level, bone quality, patient factors and other clinical variables; it should not be assumed to last a specific number of years.
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.