đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Resurfacing of the glenoid component of the shoulder joint in patients with degenerative joint disease.
- Use in adult patients undergoing shoulder surgery when glenoid resurfacing is indicated.
Clinical Applications
- Glenoid resurfacing during shoulder arthroplasty.
- Treatment of selected degenerative arthritis affecting the shoulder socket.
- Treatment of painful shoulder-joint degeneration with limited motion when the surgeon determines that glenoid resurfacing is appropriate.
Practical Considerations
- The surgeon must select the implant size and configuration to match the patient's glenoid anatomy and the planned reconstruction.
- Implantation requires appropriate surgical exposure, preparation of the glenoid, and use of the manufacturer's compatible instruments and technique.
- The device is implanted by an orthopedic surgeon, generally in a hospital or ambulatory surgery center under regional anesthesia, general anesthesia, or both.
- MRI safety and conditional-use requirements should be confirmed in the current implant labeling and based on the exact implanted components; do not assume that an implant is MRI safe without verification.
- Patient selection should account for bone quality, shoulder anatomy, infection risk, rotator-cuff status, activity level, and other factors that may affect the success of shoulder arthroplasty.
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.