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U.S. FDA Medical Device Hip Joint Prosthesis Requirements: Hip Joint Prosthesis

FDA Medical Device Definition: A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement

Registrar Corp assists Hip Joint Prosthesis companies with:

  • FDA Hip Joint Prosthesis Establishment Registration
  • FDA Hip Joint Prosthesis Listing
  • FDA Hip Joint Prosthesis Label Requirements and Exceptions
  • FDA Hip Joint Prosthesis Import Information
  • FDA Hip Joint Prosthesis Detentions (Hip Joint Prosthesis Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Hip Joint Prosthesis Manufacturers (Hip Joint Prosthesis Suppliers)
       - Hip Joint Prosthesis Distributors
       - Hip Joint Prosthesis Processors
       - Hip Joint Prosthesis Repackers
       - Hip Joint Prosthesis Relabelers
       - Hip Joint Prosthesis Exporters
       - Hip Joint Prosthesis Importers
For more information about Hip Joint Prosthesis Medical Devices, simply click below:

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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

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