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global cap resurfacing replacement shoulder
Depuy Orthopaedics
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
510K
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.
Clinical Applications
This device is commonly used in clinical scenarios involving glenohumeral osteoarthritis where joint preservation is preferred. It is particularly suitable for patients requiring shoulder resurfacing without extensive bone removal.
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.
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.