(175 days)
The Meridian® Titanium Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating that are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary or revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.
The Meridian® Titanium Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary or revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.
These femoral components will be made available in two substrate alloys: 1) Ti-6Al-4V, which meets the requirements of ASTM specification F 136 or 2) TMZF alloy (Ti-11.5 Mo-6Zr-2 Fe). The TMZF alloy is the subject of a draft ASTM specification. The Titanium plasma spray coating is CP titanium, which conforms to ASTM specification F 1580.
The provided text describes the 510(k) submission for the Meridian® Titanium Femoral Stems and states that "Fatigue endurance testing in accordance with ISO standards was presented."
However, the document does not provide any specific acceptance criteria or the reported device performance values from this fatigue endurance testing. Therefore, I cannot construct a table of acceptance criteria and reported performance or answer specific questions about the study's details like sample size, ground truth, or expert involvement.
The text only states that the testing was performed according to ISO standards and that based on this and other factors (intended use, materials, design, indications/contraindications), the device was deemed substantially equivalent to predicate devices. It does not elaborate on the results of the tests themselves, the specific ISO standards used, or the methodology.
Without this crucial information, I cannot fulfill the request for a detailed description of the acceptance criteria and the study that proves the device meets them.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.