(82 days)
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No
The device description and intended use describe a purely mechanical plug for an acetabular cup, with no mention of any computational or analytical capabilities.
No.
The device is described as a threaded plug intended to close the apical hole of acetabular cups and provide support for a polyethylene liner, rather than directly treating a medical condition or ailment.
No
The device is described as a threaded plug used to close a hole in acetabular cups and support a polyethylene liner, not to diagnose medical conditions.
No
The device description clearly indicates a physical, threaded plug intended for surgical implantation, not a software product.
Based on the provided information, 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 description clearly states that the Apex Hole Eliminator PS is a threaded plug intended to close a hole in an acetabular cup, which is an implant used in hip replacement surgery. It is a physical component used within the body during a surgical procedure.
- Lack of Diagnostic Function: The device's purpose is mechanical – to seal a hole and provide support. It does not perform any tests on biological samples to diagnose, monitor, or screen for any medical condition.
Therefore, the Apex Hole Eliminator PS is a surgical implant component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Apex Hole Eliminator PSis a threaded plug intended to close the apical hole of the Duraloo® series two-piece acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement. It can be used after insertion of the acetabular cup in a cementless technique once the cup is well seated to prevent movement of blood or particles from behind the shell through the hole or it can be placed prior to insertion of the cup if the cup is being cemented into place to prevent cement from coming through the apical hole. The Apex Hole Eliminator PS also provides support of the polyethylene liner utilized in the metal shell, assuring full, congruent, uninterrupted support of the liner within the shell, and eliminating the potential of cold flow of the liner into the apical hole of the metal shell.
Product codes
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Device Description
The Apex Hole Eliminator PSis a threaded plug intended to close the apical hole of the Duraloo® series two-piece acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement. It can be used after insertion of the acetabular cup in a cementless technique once the cup is well seated to prevent movement of blood or particles from behind the shell through the hole or it can be placed prior to insertion of the cup if the cup is being cemented into place to prevent cement from coming through the apical hole. The Apex Hole Eliminator PS also provides support of the polyethylene liner utilized in the metal shell, assuring full, congruent, uninterrupted support of the liner within the shell, and eliminating the potential of cold flow of the liner into the apical hole of the metal shell.
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
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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 (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)
DePuy Duraloc® 100C Acetabular Cup
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
510K SAFETY AND EFFECTIVENESS SUMMARY
| NAME OF FIRM: | DePuy Inc. |
|---|---|
| P.O. Box 988 | |
| Warsaw, IN 46581-0988 | |
| 510(k) CONTACT: | Cheryl Hastings |
| Manager, Clinical Affairs | |
| NOV 12 1996 | |
| TRADE NAME: | Apex Hole Eliminator PS |
| CLASSIFICATION NAME: | Prosthesis, Hip, Semi-constrained (metal uncemented) Acetabular Component (Regulation number: 888.3330) |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy Duraloc® 100C Acetabular Cup |
| Wright Medical Interseal™ Acetabular Components |
INTENDED USE AND DEVICE DESCRIPTION:
The Apex Hole Eliminator PSis a threaded plug intended to close the apical hole of the Duraloo® series two-piece acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement. It can be used after insertion of the acetabular cup in a cementless technique once the cup is well seated to prevent movement of blood or particles from behind the shell through the hole or it can be placed prior to insertion of the cup if the cup is being cemented into place to prevent cement from coming through the apical hole. The Apex Hole Eliminator PS also provides support of the polyethylene liner utilized in the metal shell, assuring full, congruent, uninterrupted support of the liner within the shell, and eliminating the potential of cold flow of the liner into the apical hole of the metal shell.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Apex Hole Eliminator PS is substantially equivalent to the apical hole plug which was cleared with the DePuy Duraloc 100C Acetabular Cup and to the apical hole plug used with the Wright Medical Interseal Acetabular Components in that they have similar designs and the same intended use. The differences between the Apex Hole Eliminator PS and the Duraloc 100C apical hole eliminator are: 1) the Apex Hole Eliminator PS is manufactured from forged Ti-6AI-4V while the Duraloc 100C apical hole eliminator is manufactured from forged Co-Cr-Mo: and 2) the Apex Hole Eliminator PS has standard threads and a taper on the trailing edge to lock it into the acetabular shell. The Duraloc 100C apical hole eliminator has interference locking threads to fasten it to the acetabular shell.