Joint Disease Clinical Trial
Official title:
Microplasty Tibial Tray Multi-Center Data Collection
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray.
FDA has cleared this device via premarket notification 510(k) K063732. By being CE Marked,
the Microplasty Tibial Tray also conforms to the essential requirements of EC Directive
93/42/EEC; in accordance to 13485:2003. The data gathered would be collated and used to
provide feedback to design engineers, support marketing efforts, and answer potential
questions from reimbursement agencies, and will serve as a part of Biomet's Post Market
Surveillance System.
Inclusion/exclusion criteria are identical to those indications and contraindications stated
in the FDA approved labeling for the device in 510(k) K063732 Surgical techniques and
patient care are to be standard for the surgeon participating in the protocol and should be
maintained the same throughout the course of the data-collection. There will be no
experimental or investigational devices used. There will be no experimental or
investigational surgical techniques used. The devices and products will be used in
accordance with their instructions for use and/or approved labeling. Any use of the device
or collection of clinical data outside of the United States should comply with all local,
state, and/or national and international regulations.
Function will be assessed through the Knee Society Score . Survivorship will be documented
by asking the surgeon to document revisions and complications.
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