(71 days)
The DePuy Porocoat HPS II Hip Prosthesis with Articul-eze taper is indicated for uncemented or cemented use as the femoral components in total hip arthroplasty 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.
The Porocoat HPS II Hip Prosthesis with Articul-eze Taper is a design modification of the Porocoat HPS II Hip prosthesis which was previously cleared by FDA for cemented use. The design modification consists of changing the diameter of the taper and neck and adding the intended use of cementless fixation. In addition, five new stem sizes (one increased diameter and four reduced length stems) are being added. The material (ASTM F75 Co-Cr-Mo alloy), manufacturing process, intended use (with the exception of the additional indication of cementless use) and the basic design of the Porocoat HPS II Hip Prosthesis with Articul-eze taper have not changed from those of the Porocoat HPS II Hip Prostheses cleared by FDA in 1984.
This document is a 510(k) summary for a medical device (DePuy Porocoat HPS II Hip Prosthesis with Articul-eze Taper). It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.
However, this document does NOT contain information about acceptance criteria, device performance metrics, or any study results in the manner requested by the prompt. This type of 510(k) submission generally focuses on demonstrating substantial equivalence based on comparisons to predicate devices, rather than presenting novel clinical study data with performance metrics against pre-defined acceptance criteria.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth, experts, or study types like MRMC or standalone performance, as this information is not present in the provided document.
To summarize, based on the provided text, the answer to all parts of your request is: The provided document does not contain the information required to answer these questions.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988 | MAR 27 1996 |
|---|---|---|
| 510(k) CONTACT: | Cheryl HastingsManager, Pre-clinical Device Evaluation | |
| TRADE NAME: | DePuy Porocoat® HPS II Hip Prosthesis withArticul-eze® Taper | |
| COMMON NAME: | Cemented or Cementless Porous Coated Hip | |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrainedporous coated uncemented prosthesis | |
| DEVICE PRODUCT CODE: | 87LPH | |
| SUBSTANTIALLYEQUIVALENT DEVICES: | Porocoat HPS II Hip Prosthesis DePuy Vision 5/8 Porocoat AML Hip Prosthesis DePuy Porocoat Prodigy Hip Prosthesis |
> DePuy Apogee Hip Prosthesis with Porocoat
INTENDED USE AND DEVICE DESCRIPTION:
The Porocoat HPS II Hip Prosthesis with Articul-eze Taper is a design modification of the Porocoat HPS II Hip prosthesis which was previously cleared by FDA for cemented use. The design modification consists of changing the diameter of the taper and neck and adding the intended use of cementless fixation. In addition, five new stem sizes (one increased diameter and four reduced length stems) are being added.
The DePuy Porocoat HPS II Hip Prosthesis with Articul-eze taper is indicated for uncemented or cemented use as the femoral components in total hip arthroplasty 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.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The subject Porocoat HPS II Prosthesis with Articul-eze taper is identical to the Porocoat HPS II Prosthesis previously cleared by FDA with the exception of the change in taper/neck design, the addition of a cementless use indication, and the addition of five new sizes. The Articul-eze taper design has previously been incorporated into the DePuy Vision AML Hip Prostheses, the Porocoat Prodigy Hip Prosthesis and the Apogee Hip Prosthesis with Porocoat. The material (ASTM F75 Co-Cr-Mo alloy), manufacturing process, intended use (with the exception of the additional indication of cementless use) and the basic design of the Porocoat HPS II Hip Prosthesis with Articul-eze taper have not changed from those of the Porocoat HPS II Hip Prostheses cleared by FDA in 1984.
§ 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.