(29 days)
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
The HA X-Series Bi-Metric® Hip Femoral Components consist of the same design and materials as the predicate devices contained in 510(k) K020580 except that the stems have been further coated with hydroxyapatitie (HA) coating. The HA coating has been added to enhance tissue adherence.
This document describes a 510(k) premarket notification for a medical device, the HA X-Series Bi-Metric® Hip Femoral Components. The application states that no clinical testing was provided for this device, as it is substantially equivalent to a legally marketed predicate device (K020580) with only the addition of a hydroxyapatite (HA) coating to enhance tissue adherence. Therefore, the required information for acceptance criteria and study details cannot be extracted from the provided text.
Specifically, the document states:
"Clinical Testing: None provided"
Without clinical testing, there are no acceptance criteria based on patient outcomes, no device performance data from a clinical trial, and no details regarding sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies. The device's approval is based on its substantial equivalence to a predicate device and non-clinical mechanical testing and engineering analysis.
§ 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.