đź“‹ FDA Reference
Depuy Global Cap Ha Resurfacing Shoulder Humeral Heads
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 ?
510(k)
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.
FDA-Cleared Indications
- Resurfacing arthroplasty of the humeral head in patients with painful shoulder joint disease or damage.
- Use in shoulder arthroplasty when the humeral head surface requires replacement while preserving the remaining humeral bone.
Clinical Applications
- Humeral head resurfacing during shoulder arthroplasty.
- Treatment of selected shoulder joint damage caused by arthritis or trauma when humeral head resurfacing is appropriate.
- Use with compatible shoulder arthroplasty components according to the manufacturer’s labeling and surgical technique.
Practical Considerations
- The implant is available in multiple sizes; the surgeon selects the size based on the patient’s anatomy, bone quality and the planned reconstruction.
- It must be used with the specified compatible instruments and components and implanted using the manufacturer’s surgical technique.
- The device is implanted in the proximal humerus and requires adequate bone stock and fixation for resurfacing arthroplasty.
- MRI safety depends on the complete implanted construct and the applicable manufacturer’s conditions. Patients should provide the exact implant information to the MRI facility before scanning.
- Contraindications, warnings and precautions include factors such as infection, inadequate bone stock or other conditions that could prevent stable fixation; the current device labeling should be reviewed.
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.