(64 days)
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No
The description focuses on the physical design and materials of the hip prosthesis, with no mention of AI or ML capabilities.
No
The device is a hip implant, which is a medical device used for structural replacement rather than for treating a disease or condition in a therapeutic manner.
No
The device is a femoral component for total hip arthroplasty, which is a prosthetic implant used to replace a damaged hip joint, not a tool for diagnosing medical conditions.
No
The device description clearly describes a physical implant (femoral hip prosthesis) made of Co-Cr-Mo with a porous coating of beads. There is no mention of software as the primary component or function of the device.
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. These tests are performed outside of the body.
- Device Description and Intended Use: The provided information clearly describes a femoral component for total hip arthroplasty. This is a surgical implant designed to be placed inside the body to replace a damaged hip joint.
- Lack of Diagnostic Activity: There is no mention of this device performing any tests on biological samples or providing diagnostic information. Its function is purely mechanical and structural, replacing a damaged anatomical part.
Therefore, based on the provided information, the Graded Porosity AML is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
87LPH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hip joints
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
DePuy 5/8 Porous Coated AML Hip Prosthesis, DePuy Proximally Porous Coated AML, DePuy Solution Hip Prosthesis
Reference Device(s)
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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
1 1996 OCT ...
K962923
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Cheryl Hastings
Manager, Clinical Affairs |
| TRADE NAME: | DePuy Graded Porosity AML Hip Prosthesis |
| COMMON NAME: | Cemented or Cementless Porous Coated Hips |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrained
porous coated uncemented prosthesis |
| DEVICE PRODUCT CODE: | 87LPH |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | > DePuy 5/8 Porous Coated AML Hip Prosthesis
DePuy Proximally Porous Coated AML
DePuy Solution Hip Prosthesis |
INTENDED USE AND DEVICE DESCRIPTION:
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.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Graded Porosity AML Hip is manufactured from the same material and has the same substrate geometry as the 5/8 Porous Coated and Proximally Porous Coated AML Hip Prostheses. The only difference between the Graded Porosity AML and the 5/8 and Proximally Porous Coated AMLs are that the Graded Porosity AML is a fully porous coated prosthesis and the porous coating is non-homogenous in bead size, pore size and porous coating thickness. The Graded Porosity AML is also similar to the Solution Hip Prosthesis in that both are fully porous coated and both are manufactured from the same material.
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