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copeland resurfacing humeral heads
Biomet Manufacturing
Summary: The Copeland Resurfacing Humeral Heads is a device used primarily for shoulder arthroplasty in patients with osteoarthritis. Key evidence suggests varying outcomes in terms of implant migration and revision rates.
FDA Clearance Information
Pathway
510K
Number
K010664 ↗
Decision Date
April 5, 2001
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The Copeland Resurfacing Humeral Heads was cleared by the FDA via the 510(k) pathway on April 5, 2001. It is manufactured by Biomet Manufacturing and classified as a Class 2 device.
What It Is
The Copeland Resurfacing Humeral Heads is a prosthetic device designed for humeral head resurfacing in shoulder arthroplasty. It is intended to treat conditions such as gleno-humeral osteoarthritis by providing a smooth articular surface.
Clinical Applications
This device is commonly used in clinical scenarios involving shoulder arthroplasty, particularly in patients with osteoarthritis or cuff tear arthropathy. It serves as an alternative to total shoulder arthroplasty in certain cases.
Evidence Summary
The available literature includes 11 studies, comprising prospective and randomized controlled trials, with publication dates ranging from 2015 to 2025. These studies evaluate clinical outcomes, implant migration, and revision rates.
Reported Outcomes
Published studies report that the Copeland Resurfacing Humeral Heads shows varying outcomes in terms of implant migration and revision rates. One study noted a total translation of 0.75 at 5 years, while another reported a cumulative risk of revision at 5 years as 29%. Clinical outcomes at a mean follow-up of 5 years were also assessed.
Safety Profile
Reported complications include high revision rates and implant migration. Some studies indicated no loose implants at revision, but highlighted the potential for progressive glenoid wear and loosening.
Evidence Limitations
Evidence gaps include limited long-term data on clinical outcomes and safety. Some studies have small sample sizes, and further research is needed to compare outcomes with other shoulder arthroplasty options.
Frequently Asked Questions
What are the clinical indications for Copeland Resurfacing Humeral Heads?
The device is indicated for use in shoulder arthroplasty, particularly in patients with gleno-humeral osteoarthritis or cuff tear arthropathy.
What outcomes have been reported in clinical studies?
Clinical studies have reported outcomes such as implant migration, revision rates, and clinical scores at follow-up intervals.
What complications have been reported?
Safety data from evidence indicate complications such as high revision rates and potential implant migration.
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.