(79 days)
The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.
The ZMR Revision Taper Hip Prosthesis is a femoral stem straight femoral stem manufactured from Tivanium® (Ti-6Al-4V) Alloy, and intended for cementless use in revision hip arthroplasty. This device has two modular junctions: a headthess k junction and a midstem junction. Three components are intraoperatively assembled to construct the device: a proximal segment or "body," a distal stem, and a compression nut.
The provided text is a 510(k) premarket notification for a medical device (ZMR Hip System-Revision Taper) and does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document establishes substantial equivalence to predicate devices based on intended use, material, and design principles, but it does not detail specific performance studies, acceptance criteria, or the methodology typically found in clinical trials or validation studies for AI/device performance. There is no mention of a "device performance" section in this document.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study from the provided text. The document is for a medical device regulatory filing, not a performance study report.
§ 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.