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grs glenoid resurfacing system
Arthrosurface
Summary: The GRS Glenoid Resurfacing System is a medical device used for shoulder joint resurfacing, primarily by orthopedic surgeons. It is designed to address joint degeneration and improve shoulder function.
FDA Clearance Information
Pathway
510K
Number
K091196 ↗
Decision Date
October 27, 2009
Product Code
KWS
Device Class
Class 2
Evidence
0 studies
The GRS Glenoid Resurfacing System, manufactured by Arthrosurface, was cleared via the FDA 510k pathway on October 27, 2009. It is a Class 2 device under product code KWS.
What It Is
The GRS Glenoid Resurfacing System is an orthopedic implant designed to resurface the glenoid, or socket, of the shoulder joint. It is used to treat patients with degenerative joint disease, providing a smooth surface for articulation and reducing pain. The system typically involves a metal implant that is affixed to the glenoid, allowing for improved joint movement and function.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in cases of shoulder arthritis or other degenerative conditions affecting the glenoid. It is suitable for patients who require joint resurfacing but may not need a full shoulder replacement. The system is typically used in hospital or surgical center settings, and is applicable to adult patients experiencing joint pain and limited mobility.
Indications for Use
The FDA indications suggest that the GRS Glenoid Resurfacing System is intended for patients with shoulder joint degeneration, such as arthritis, where resurfacing of the glenoid can alleviate pain and improve function. It is a less invasive alternative to total shoulder replacement.
Practical Considerations
Clinicians should consider the size and fit of the implant for each patient, ensuring compatibility with the patient's anatomy. Proper surgical technique is crucial for optimal outcomes, and familiarity with the system's components and instrumentation is recommended for successful implantation.
Frequently Asked Questions
What is the GRS Glenoid Resurfacing System used for?
It is used for resurfacing the glenoid in the shoulder joint to treat degenerative conditions like arthritis.
What specialties typically use this device?
Orthopedic surgeons primarily use this device, especially those specializing in shoulder surgeries.
What are the FDA-cleared indications?
The device is indicated for patients with shoulder joint degeneration, providing a resurfacing option to alleviate pain and improve function.
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.