(49 days)
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. .
- Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. .
- . Proximal femoral fractures
- . Avascular necrosis of the femoral head
- . Non-union of proximal femoral neck fractures
- Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa ● vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomaliacia, osteoporosis, pseudarthrosis conversion and structural abnormalities.
The Consensus Acetabular Shell System consists of four modular shell options which mate with currently marketed polyethelyne insert components for replacement of the acetabular surface during total hip arthroplasty. The shells are designed to be implanted without bone cement. Cementless (press-fit) fixation is achieved by coating the external surface of the cup with commercially pure (CP) titanium sintered beads.
All of the shell options have the following common features:
- The substrate material of the Consensus Shells is titanium alloy (ASTM F136, Ti-6AI-4V) ●
- · The shell is porous coated with commercially pure (CP) titanium sintered beads (ASTM F67, irregular bead geometry).
- · The shells have the same internal locking mechanism as the previously cleared Consensus Acetabular Shells (K922561).
- · The apical dome hole of the shells is threaded to accept an impaction tool for implanting the component. After implantation and the impaction tool is removed, a threaded titanium (ASTM F67 or F136) hole plug can be inserted into the threaded hole to prevent migration of unwanted particles through the dome hole.
The following shell options are available:
- · Total Hemispherical in no screw holes or three (3) quadrant screw holes options.
- · Hemispherical with rim flare in no screw holes or three (3) quadrant screw holes options.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets specific criteria. The document is a 510(k) summary for a medical device (Consensus Acetabular Shell System), which primarily focuses on device description, intended use, and demonstrating substantial equivalence to previously cleared predicate devices.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on this text.
§ 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.