(64 days)
The Graded Porosity AML is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty.
It is a fully porous coated, cast Co-Cr-Mo femoral hip prosthesis available in four standard and four modified medial aspect (MMA) sizes. The porous coating consists of Co-Cr-Mo beads of various sizes. The stem is divided proximally/distally into five equal zones. A layer of the smallest beads is applied to the entire stem. A layer of the next larger beads is then applied to the most proximal 4 zones, a layer of the next larger beads is applied to the most proximal 3 zones etc. until the largest beads are applied as the outer layer of beads in the most proximal zone. The stem is sintered and HIPed once to attach all of the beads. The end result is a stem with 5 layers of different sized beads proximally, gradually reducing to 1 layer of the smallest beads distally.
This document is a 510(k) summary for a medical device (DePuy Graded Porosity AML Hip Prosthesis). It describes the device's intended use, description, and basis of substantial equivalence to predicate devices.
However, it does not contain any information about acceptance criteria, device performance metrics, studies with test sets, ground truth establishment, sample sizes for training or testing, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information in the format of the table and numbered points based on the provided text. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance study data.
§ 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.