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depuy global cap ha resurfacing shoulder humeral heads
Depuy Orthopaedics
Summary: The Depuy Global Cap HA Resurfacing Shoulder Humeral Heads is a medical device used for shoulder joint resurfacing. It is primarily used by orthopedic surgeons to treat patients with shoulder joint damage.
FDA Clearance Information
Pathway
510K
Number
K033516 ↗
Decision Date
December 3, 2003
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The Depuy Global Cap HA Resurfacing Shoulder Humeral Heads was cleared through the FDA 510(k) pathway on December 3, 2003. It is manufactured by Depuy Orthopaedics and classified as a Class 2 device under product code HSD.
What It Is
The Depuy Global Cap HA Resurfacing Shoulder Humeral Heads is a prosthetic device designed for shoulder joint resurfacing. It is made with hydroxyapatite (HA) coating to promote bone integration. This device is used to replace the damaged surface of the humeral head, preserving more of the patient's natural bone compared to traditional shoulder replacements.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in procedures involving shoulder arthroplasty. It is suitable for patients with osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the shoulder. The device is typically used in hospital or surgical center settings, and it is most relevant to orthopedic surgeons specializing in joint reconstruction.
Indications for Use
The FDA indications suggest that this device is intended for patients with shoulder joint damage due to arthritis or trauma. It is used when the humeral head surface needs resurfacing rather than full replacement.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies. It is important to ensure compatibility with the patient's bone structure and to use precise surgical techniques to achieve optimal outcomes. Surgeons should be familiar with the specific instrumentation and implantation process for this device.
Frequently Asked Questions
What is Depuy Global Cap HA Resurfacing Shoulder Humeral Heads used for?
It is used for resurfacing the humeral head in shoulder joints affected by arthritis or trauma.
What specialties typically use this device?
Orthopedic surgeons specializing in joint reconstruction and shoulder arthroplasty typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with shoulder joint damage due to arthritis or trauma, requiring resurfacing of the humeral head.
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.