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axiom orthopaedics shoulder resurfacing system
Axiom Orthopaedics
Summary: The Axiom Orthopaedics Shoulder Resurfacing System is a medical device used for shoulder joint resurfacing, primarily in patients with joint degeneration. It is typically used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K061862 ↗
Decision Date
August 28, 2006
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The Axiom Orthopaedics Shoulder Resurfacing System was cleared through the FDA 510k pathway on August 28, 2006. It is manufactured by Axiom Orthopaedics and classified as a Class 2 device.
What It Is
The Axiom Orthopaedics Shoulder Resurfacing System is designed to restore the shoulder joint surface in patients with degenerative joint disease. It involves capping the humeral head with a metal prosthesis, preserving more of the patient's natural bone compared to traditional shoulder replacement. This device aims to relieve pain and improve joint function while maintaining more of the natural anatomy.
Clinical Applications
This device is commonly used in orthopedic surgery, specifically in procedures addressing shoulder arthritis or other degenerative conditions. It is suitable for patients who are younger or more active, as it preserves more bone and allows for a more natural range of motion. The device is typically used in hospital operating rooms or specialized orthopedic centers.
Indications for Use
The FDA indications suggest that this device is intended for patients with shoulder joint degeneration, such as osteoarthritis, where joint resurfacing is deemed appropriate. It is particularly beneficial for those who are not candidates for total shoulder replacement.
Practical Considerations
The Axiom Orthopaedics Shoulder Resurfacing System comes in various sizes to accommodate different patient anatomies. Surgeons should be familiar with the specific surgical technique required for implantation, and compatibility with existing bone structure should be assessed preoperatively.
Frequently Asked Questions
What is the Axiom Orthopaedics Shoulder Resurfacing System used for?
It is used for resurfacing the shoulder joint in patients with degenerative joint disease to relieve pain and improve function.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder procedures commonly use this device.
What are the FDA-cleared indications?
It is indicated for patients with shoulder joint degeneration, such as osteoarthritis, where joint resurfacing is appropriate.
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.