đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Shoulder joint resurfacing in patients with degenerative joint disease.
- Use as a prosthetic replacement for the humeral head when shoulder resurfacing is clinically appropriate.
Clinical Applications
- Humeral head resurfacing during shoulder arthroplasty.
- Treatment of labeled degenerative shoulder joint disease when joint resurfacing is selected.
- Use of a size-matched metal humeral component to restore the articular surface of the shoulder.
Practical Considerations
- The implant is available in multiple sizes; the surgeon must match the component to the patient’s humeral head and available bone.
- Preoperative imaging and assessment are needed to evaluate bone quality, joint anatomy, alignment, and whether resurfacing is appropriate.
- Implantation requires an orthopedic surgical approach, appropriate instrumentation, and familiarity with the manufacturer’s surgical technique.
- MRI safety depends on the complete implanted system and current manufacturer labeling. Patients should provide implant information to the MRI facility before scanning.
- Potential contraindications and complications include infection, poor bone quality, fracture, loosening, wear, instability, nerve or blood-vessel injury, and the need for revision surgery.
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.