(14 days)
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- Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
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- Revision of failed femoral head replacements.
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- When alternative reconstructive techniques are not viable.
- When arthrodesis is contraindicated. 4.
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- Avascular necrosis or fracture of the femoral head.
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- Congenital defects that will allow adequate function of the system.
Protract Press-Fit Hip Stem - HA Coated
The provided text is a clearance letter from the FDA for a medical device called the "Protract Press-Fit Hip Stem - HA Coated." It does not contain any information about acceptance criteria, the study design, device performance data, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input document. The document primarily serves as an official communication from the FDA stating that the device has been deemed "substantially equivalent" to predicate devices and can be marketed. It lists the indications for use but does not detail the technical performance or supporting clinical study data.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. 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.(b)
Classification. Class II.