BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER

  • Model / Serial
    Catalog Number 00-4301-006/018-00.   All lot numbers.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia, Canada, and Thailand.
  • Product Description
    BIGLIANI/FLATOW¿ THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for implantation of the Zimmer¿ Trabecular Metal Humeral and/or Zimmer¿ Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4301-006/018-00. || The intramedullary reamer manual surgical instrument is used in the surgical procedure to implant the Zimmer¿ Trabecular Metal Humeral and Zimmer¿ Trabecular Metal Reverse Shoulder Systems. The reamer is used to open the mid to distal humeral canal to accept the implant. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. is used to open the mid to distal humeral canal to accept the implant.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA