(51 days)
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No
The device description and performance data focus on the material and mechanical properties of a physical implant component, with no mention of software, algorithms, or data processing.
Yes
The device is an implantable component for a total hip system, used to treat various conditions like arthritis, avascular necrosis, and fractures, which falls under the definition of a therapeutic device designed to alleviate or cure a disease or condition.
No
The provided text describes the Consensus® Apex Dome Hole Plug (PMMA) as an implantable component for a total hip system used to treat various bone and joint conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a physical component made of polymethylmethacrylate (PMMA) intended for use in hip replacement surgery. It is a single-use device provided sterile.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The Consensus® Apex Dome Hole Plug (PMMA) is a physical implant made of polymethylmethacrylate (PMMA) intended for use within the human body as part of a total hip replacement system.
- Intended Use: The intended uses listed are all related to surgical procedures and the treatment of conditions affecting the hip joint within the body.
The device is a surgical implant, not a diagnostic tool used for testing biological samples.
N/A
Intended Use / Indications for Use
The CONSENSUS® Apex Dome Hole Plug (PMMA) is indicated for use in:
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- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
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- Osteoarthrosis involving femoral and acetabular articular surfaces.
-
- Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
-
- Fracture-dislocation of the hip.
-
- Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
Product codes
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Device Description
The Consensus® Apex Dome Hole Plug (PMMA) is intended for use with the Consensus® Total Hip System as an addition to the metal acetabular shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Apex Dome Hole Plug (PMMA) is designed for use with size compatible Consensus® Total Hip System components:
Porous coated Acetabular Shell
Nonporous Acetabular Shell
Acetabular Insert, UHMWPE
The Concensus® Apex Dome Hole Plug (PMMA) will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.
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
Performance Data: The Consensus® Apex Dome Hole Plug (PMMA), device performs with substantial equivalence to predicate devices.
Clinical Data: None Required
Conclusions from Non-clinical and Clinical Data: The Consensus® Apex Dome Hole Plug (PMMA), is substantially equivalent to predicate devices.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
KL0340
ATTACHMENT 8
Summary of Safety and Effectiveness 510(k) SUMMARY
US MEDICAL PRODUCTS, INC. CONSENSUS® Apex Dome Hole Plug (PMMA)
MAR 1 5 1996
| US Medical Products, Inc.
12201 Technology Blvd.
Suite 100
Austin, Texas 78727 | William N. Thompson, Director
Quality Assurance and Regulatory Affairs
Voice (512) 257-4835
Fax (512) 257-8300
Date of Preparation: | 15 Dec 1995 |
| ----------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------- | ------------- |
|---|
| Trade Name: | CONSENSUS® Apex Dome Hole Plug |
|---|---|
| Common Name: | Hip replacement prosthesis, Acetabular Shell Apex Dome Hole |
| Plug (PMMA) |
Classification Name: Class II device, under the following classification:
Prosthesis, Hip, Semi-Constrained Metal/ Polymer classification 21 CFR 888.3350
Substantial Equivalence: equivalent Apex Dome Hole Plug (PMMA) components are as follows:
Consensus® Acetabular Cement Pods K922561 SE 07/21/93
Device Description: The Consensus® Apex Dome Hole Plug (PMMA) is intended for use with the Consensus® Total Hip System as an addition to the the metal acetabilar shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Apex Dome Hole Plug (PMMA) is designed for use with size compatible Consensus® Total Hip System components:
| Porous coated Acetabular Shell | K922561 | SE 07/21/93 |
|---|---|---|
| Nonporous Acetabular Shell | K922561 | SE 07/21/93 |
| Acetabular Insert, UHMWPE | K922561 | SE 07/21/93 |
1
The Concensus® Apex Dome Hole Plug (PMMA) will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.
Intended Use: The CONSENSUS® Apex Dome Hole Plug (PMMA) is indicated for use in:
-
- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
-
- Osteoarthrosis involving femoral and acetabular articular surfaces.
-
- Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
-
- Fracture-dislocation of the hip.
-
- Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
Summary of Technological Characteristics: The Consensus® Apex Dome Hole Plug (PMMA), is designed function as an optional plug for the acetabular shell dome apex hole. The Concensus® Apex Dome Hole Plug (PMMA), will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.
Performance Data: The Consensus® Apex Dome Hole Plug (PMMA), device performs with substantial equivalence to predicate devices.
Clinical Data: None Required
Conclusions from Non-clinical and Clinical Data: The Consensus® Apex Dome Hole Plug (PMMA), is substantially equivalent to predicate devices.
Other Necessary Information: None Required