Osteoporosis Clinical Trial
Official title:
Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
The primary objective of this prospective clinical data collection is to evaluate
survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Secondary
objectives include validation of implant sizing and hardware options as well as collection of
mid-term clinical outcomes including adverse events, scapular notching, and Constant Score.
All shoulders on which data will be collected are legally marketed and none of the devices
are investigational or experimental. FDA has cleared this device via Premarket Notification
510(k) K080642. This data collection effort will document the clinical outcomes of the
Comprehensive® Reverse shoulders. The data gathered will be collated and used to provide
feedback to designing engineers, support marketing efforts, and answer potential questions
from reimbursement agencies.
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