(92 days)
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatio 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
EMPHASYS Acetabular Cups are indicated for cementless use only.
The EMPHASYS Acetabular System includes porous-coated acetabular shells in three configurations (No-Hole, 3-Hole and Multi-Hole) and AOX polyethylene liners in three configurations (Neutral, +4 Neutral and ELV).
This is a K (Premarket Notification) document for the EMPHASYS Acetabular System, a medical device. The document does not describe acceptance criteria for a diagnostic/AI device or a study proving that such a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence of the subject device (an acetabular system for hip replacement) to legally marketed predicate devices through various performance tests.
Therefore, I cannot extract the information requested as it is not present in the provided document. The document primarily deals with the mechanical and material performance of a hip implant, not an AI or diagnostic device that would involve a test set, ground truth, or expert review.
§ 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.