(85 days)
The TriFlange II Acetabular Cup System is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The patient specific TriFlange II Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated acetabular cup with three patient specific illial, ischial and pubic flanges added to reinforce weak acetabula. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges.
The provided text is a 510(k) summary for the TriFlange II Acetabular Cup System, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting on a study with acceptance criteria for device performance as would be expected for a novel AI/software device.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in the provided document. The 510(k) summary focuses on device description, intended use, indications for use, and a comparison to predicate devices to establish substantial equivalence.
The document does not contain the information required to answer your specific questions.
§ 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.