(81 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 Porous Revision Hip Prosthesis is a 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 head/neck 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.
I am sorry, but the provided text describes the Zimmer, Inc. ZMR™ Hip System-Porous Revision, a femoral hip prosthesis, and its clearance process with the FDA. This documentation is a 510(k) submission, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device.
The information provided does not include details about acceptance criteria, device performance, or any studies using AI or algorithms. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
The document is purely a regulatory filing for a physical medical device (a hip replacement system).
§ 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.