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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 ?
510(k)
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.
FDA-Cleared Indications
- Humeral head resurfacing arthroplasty for treatment of glenohumeral osteoarthritis.
- Use in patients requiring replacement or resurfacing of the humeral head, according to the device labeling.
Clinical Applications
- Resurfacing the humeral head during shoulder arthroplasty.
- Treating glenohumeral osteoarthritis when humeral head resurfacing is appropriate.
- Preserving proximal humeral bone compared with removal of the humeral head for a stemmed implant.
Reported off-label uses
- Treatment of selected patients with cuff tear arthropathy when the rotator cuff and subscapularis function are adequate; this use depends on patient selection and may not be covered by the device labeling.
- Treatment of other painful humeral head conditions, such as selected post-traumatic deformity or osteonecrosis, as described in orthopedic practice and literature.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The implant must be matched to the patient’s humeral head anatomy; available sizes and sizing technique depend on the specific system and its labeling.
- It is intended for use with compatible surgical instruments and components; mixing components from different manufacturers may be contraindicated.
- The procedure requires adequate bone quality and appropriate shoulder soft-tissue function. Severe bone loss, infection, or inadequate rotator cuff function may make resurfacing inappropriate.
- MRI safety and conditional-use parameters should be confirmed from the current implant labeling and the exact implanted components. Patients should tell MRI staff about the implant before scanning.
- Expected longevity depends on age, activity, bone quality, implant positioning, and shoulder pathology. Revision may eventually be necessary.
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.