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copeland resurfacing heads
Biomet
Summary: Copeland resurfacing heads are used in humeral head resurfacing arthroplasty, primarily for treating gleno-humeral osteoarthritis. Key evidence highlights include migration patterns and revision rates compared to other implants.
FDA Clearance Information
Pathway
510K
Number
K003044 ↗
Decision Date
December 13, 2000
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The Copeland resurfacing heads were cleared by the FDA via the 510(k) pathway on December 13, 2000. Manufactured by Biomet, they are classified as Class 2 devices.
What It Is
The Copeland resurfacing heads are orthopedic devices designed for humeral head resurfacing arthroplasty. They are intended to treat conditions like gleno-humeral osteoarthritis by resurfacing the humeral head, preserving bone stock, and potentially delaying the need for total shoulder arthroplasty.
Clinical Applications
Commonly used in patients with gleno-humeral osteoarthritis, the Copeland resurfacing heads are an option for those seeking to maintain joint function and delay more invasive procedures. They are also considered in cases of cuff tear arthropathy with preserved subscapularis function.
Evidence Summary
The literature includes 11 studies, comprising prospective, randomized controlled trials, and other observational designs, with publication dates ranging from 2015 to 2025. These studies explore clinical outcomes, migration patterns, and revision rates.
Reported Outcomes
Published studies report that the Copeland resurfacing heads show varying degrees of implant migration and revision rates. A randomized controlled trial indicated a 29% cumulative risk of revision at 5 years, with a total translation of 0.75 mm. Clinical outcomes assessed through scores like the Constant Shoulder Score and WOOS show moderate improvements.
Safety Profile
Reported complications include high revision rates and implant loosening. Some studies highlight early migration as a predictor of later revision, emphasizing the need for careful patient selection and follow-up.
Evidence Limitations
The evidence is limited by small sample sizes and short follow-up periods in some studies. Further research is needed to assess long-term outcomes and compare the efficacy of resurfacing heads with total shoulder arthroplasty.
Frequently Asked Questions
What are the clinical indications for Copeland resurfacing heads?
They are indicated for humeral head resurfacing in patients with gleno-humeral osteoarthritis and cuff tear arthropathy with preserved subscapularis function.
What outcomes have been reported in clinical studies?
Studies report moderate improvements in clinical scores and a 29% cumulative risk of revision at 5 years.
What complications have been reported?
Complications include high revision rates and implant loosening, with early migration predicting later revision.
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.