(71 days)
Porocoat HPS II Hip Prosthesis, DePuy Vision 5/8 Porocoat AML Hip Prosthesis, DePuy Porocoat Prodigy Hip Prosthesis
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No
The summary describes a mechanical hip prosthesis with design modifications and new sizes, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a hip prosthesis designed to replace damaged hip joints, which is a therapeutic intervention.
No
The device is a hip prosthesis, which is an implant used to replace damaged hip joints. Its purpose is therapeutic through physical replacement, not diagnostic.
No
The device description clearly describes a physical hip prosthesis made of Co-Cr-Mo alloy, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a hip prosthesis, which is an implantable device used to replace a damaged hip joint. This is a surgical implant, not a device used for testing samples outside the body.
The information provided focuses on the physical characteristics, materials, and surgical application of the device, which are typical for a non-IVD medical device.
N/A
Intended Use / Indications for Use
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.
Product codes
87LPH
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Porocoat HPS II Hip Prosthesis DePuy Vision 5/8 Porocoat AML Hip Prosthesis DePuy Porocoat Prodigy Hip Prosthesis
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
11960172
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 | MAR 27 1996 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------|
| 510(k) CONTACT: | Cheryl Hastings
Manager, Pre-clinical Device Evaluation | |
| TRADE NAME: | DePuy Porocoat® HPS II Hip Prosthesis with
Articul-eze® Taper | |
| COMMON NAME: | Cemented or Cementless Porous Coated Hip | |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrained
porous coated uncemented prosthesis | |
| DEVICE PRODUCT CODE: | 87LPH | |
| SUBSTANTIALLY
EQUIVALENT 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.