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glenoid resurfacing component-3m-10816
3M
Summary: The glenoid resurfacing component by 3M is a device used in shoulder resurfacing procedures, primarily for treating arthritis and related conditions. Key evidence highlights its use in young, active patients with promising results in reducing wear and metal sensitivity.
FDA Clearance Information
Pathway
510K
Number
K831233 ↗
Decision Date
June 3, 1983
Product Code
KWT
Device Class
Class 2
Evidence
0 studies
The glenoid resurfacing component-3m-10816 by 3M was cleared through the FDA 510(k) pathway on June 3, 1983. It is classified as a Class 2 device under product code KWT.
What It Is
The glenoid resurfacing component is designed for shoulder resurfacing, a procedure that conserves bone and treats conditions like arthritis and avascular necrosis. It is intended for use in patients requiring shoulder joint resurfacing to improve joint function and reduce pain.
Clinical Applications
This device is commonly used in clinical scenarios involving young, active patients with glenohumeral arthritis, avascular necrosis, or rotator cuff arthropathy. It is particularly suitable for patients concerned about implant longevity and those needing high physical activity levels.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs, prospective, and retrospective studies, with publication years ranging from 2017 to 2023. These studies explore the efficacy and safety of the device in shoulder resurfacing.
Reported Outcomes
Published studies report that the glenoid resurfacing component shows promising results in reducing wear and metal sensitivity, making it suitable for young, active patients. Biologic resurfacing combined with humeral head replacement has shown positive outcomes in terms of joint function and patient satisfaction.
Safety Profile
Reported complications include neuropathy due to paralabral ganglion cysts and potential issues related to implant longevity. However, the ceramic-coated surface of the device reduces wear and metal sensitivity to clinically unimportant levels.
Evidence Limitations
Evidence gaps include a lack of long-term follow-up data and limited studies focusing on diverse patient demographics. Further research is needed to establish standardized rehabilitation protocols and to explore outcomes in different clinical settings.
Frequently Asked Questions
What are the clinical indications for glenoid resurfacing component-3m-10816?
The device is indicated for shoulder resurfacing in patients with conditions such as arthritis, avascular necrosis, and rotator cuff arthropathy, particularly in young, active individuals.
What outcomes have been reported in clinical studies?
Clinical studies have reported positive outcomes in terms of joint function improvement and patient satisfaction, with reduced wear and metal sensitivity.
What complications have been reported?
Safety data indicate complications such as neuropathy from paralabral ganglion cysts and potential implant longevity issues, though wear and metal sensitivity are minimized.
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.