ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT

  • Modèle / numéro de série
    Catalog Number 00-4310-008/014-17  All lot numbers.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer¿ Trabecular Metal Humeral and/or Zimmer¿ Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4310-008/014-17. || The distal pilot manual surgical instrument is used in the surgical procedure to implant the Zimmer¿ Trabecular Metal Humeral and Zimmer¿ Trabecular Metal Reverse Shoulder Systems. The distal pilot is attached to the proximal reamer during proximal reaming and to the proximal provisional during trialing. In both of these cases the distal pilot is used to provide alignment for the proximal devices. 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.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA

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  • Modèle / numéro de série
    Catalog Number 00-4310-008/018-13  All Lot Numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer¿ Trabecular Metal Humeral and/or Zimmer¿ Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4310-008/018-13. || The distal pilot manual surgical instrument is used in the surgical procedure to implant the Zimmer¿ Trabecular Metal Humeral and Zimmer¿ Trabecular Metal Reverse Shoulder Systems. The distal pilot is attached to the proximal reamer during proximal reaming and to the proximal provisional during trialing. In both of these cases the distal pilot is used to provide alignment for the proximal devices. 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.
  • Manufacturer