(39 days)
- Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
- Revision of failed femoral head replacements.
- When alternative reconstructive techniques are not viable.
- When arthrodesis is contraindicated.
- Avascular necrosis or fracture of the femoral head.
- Congenital defects that will allow adequate function of the system.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria and study details for the "Protract Press Fit Hip Stem" device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device already on the market. It lists the indications for use but does not include:
- A table of acceptance criteria or reported device performance.
- Information about sample sizes, data provenance, or expert qualifications for a test set.
- Details on adjudication methods, MRMC studies, or standalone algorithm performance.
- The type of ground truth used or the sample size and ground truth establishment for a training set.
The FDA letter grants market clearance based on substantial equivalence, and typically, the detailed performance data from such studies would be found in the 510(k) submission itself, not in the clearance letter.
§ 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.