📊 Evidence-Based Reference
Global Cap Resurfacing Replacement Shoulder
Summary: The Global Cap Resurfacing Replacement Shoulder by Depuy Orthopaedics is a device used for shoulder arthroplasty, primarily in cases of osteoarthritis. Key evidence highlights include improved patient-reported outcomes and minimal perioperative complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K031971 ↗
Decision Date ?
September 24, 2003
Product Code ?
HSD
Device Class ?
Class 2
Evidence ?
0 studies
The Global Cap Resurfacing Replacement Shoulder was cleared by the FDA via the 510(k) pathway on September 24, 2003. It is manufactured by Depuy Orthopaedics and classified as a Class 2 medical device.
What It Is
The Global Cap Resurfacing Replacement Shoulder is a prosthetic device designed to replace the surface of the humeral head in shoulder arthroplasty. It is intended for patients with shoulder osteoarthritis, providing a less invasive option compared to total joint arthroplasty.
FDA-Cleared Indications
- Shoulder arthroplasty for selected conditions affecting the humeral head and glenohumeral joint.
- Resurfacing replacement of the humeral head when the articular surface is damaged.
- Treatment of painful shoulder joint disease, including osteoarthritis, when the patient is appropriate for resurfacing.
Clinical Applications
- Humeral head resurfacing during shoulder arthroplasty.
- Treatment of selected glenohumeral osteoarthritis with preservation of the humeral shaft.
- Replacement of a damaged humeral head articular surface when extensive bone removal is not required.
- Use in shoulder replacement surgery selected by the orthopedic surgeon based on bone quality, joint anatomy and soft-tissue function.
Evidence Summary
The available literature includes six studies, comprising randomized controlled trials, case series, and retrospective analyses, published between 2014 and 2020. These studies evaluate the device's efficacy, safety, and patient outcomes.
Reported Outcomes
Published studies report significant improvements in patient-reported outcomes, such as the Constant-Murley score and visual analog scale for pain, following revision surgery. The Dutch Simple Shoulder Test also showed significant improvement. These findings suggest the device's effectiveness in enhancing shoulder function and reducing pain.
Safety Profile
Reported complications include minimal perioperative complications, as noted in one study. The device is associated with limited bone loss during revision, which is advantageous compared to total joint arthroplasty.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to fully understand the long-term stability and bone remodeling effects of the device.
Practical Considerations
- The implant is available in multiple sizes; the surgeon selects the component based on imaging, intraoperative measurement and the patient's humeral head anatomy.
- It is intended for use as part of shoulder arthroplasty and must be matched to compatible components when additional implants are required.
- Appropriate bone quality and functioning shoulder soft tissues are important for fixation and clinical results.
- MRI safety and conditional-use information should be confirmed from the current implant labeling and the patient's implant records before an MRI examination.
- Potential contraindications and complications include infection, fracture, loosening, instability, implant wear and persistent pain; patient selection and surgical technique are important.
Frequently Asked Questions
What are the clinical indications for Global Cap Resurfacing Replacement Shoulder?
The device is indicated for patients with glenohumeral osteoarthritis requiring shoulder resurfacing.
What outcomes have been reported in clinical studies?
Studies report improvements in the Constant-Murley score, pain reduction, and enhanced shoulder function.
What complications have been reported?
Safety data indicate minimal perioperative complications and limited bone loss during revision surgery.
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.