(72 days)
Osteonics® Omnifit® UHMWPE Acetabular Shell Cement Spacer System, Osteonics® Acetabular Screw Hole Plugs, Osteonics® Universal Cement Plug
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No
The device description and intended use clearly describe a mechanical component (screw hole plugs) with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device's purpose is to occlude unused screw holes in an acetabular shell component, acting as an accessory rather than directly treating or mitigating a disease or condition.
No
This device is described as a "screw hole plug" intended to occlude unused screw holes in an acetabular shell component. Its function is to prevent bone cement intrusion and debris migration, not to diagnose a condition.
No
The device description clearly states the device is a physical plug manufactured from low density polyethylene, which is a hardware component.
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 Function: The Osteonics® Screw Hole Plugs are physical components designed to occlude screw holes in an acetabular shell during hip replacement surgery. They are used in vivo (within the body) during a surgical procedure.
- Intended Use: Their intended use is to prevent cement intrusion and debris migration, not to analyze biological samples for diagnostic purposes.
The description clearly indicates a surgical implant accessory, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Osteonics® Screw Hole Plugs are intended to occlude the unused dome screw holes of any Osteonics acetabular shell component. The Osteonics® Screw Hole Plugs will be used either with or without bone cement depending upon the labeled indications of the associated acetabular shell component. The Osteonics® Screw Hole Plugs do not carry their own indications and contraindications, but-as accessories to acetabular shell components -- would be subject to all of the indications and contraindications of the associated acetabular shells.
Product codes
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Device Description
The Osteonics® Screw Hole Plugs are small circular plugs which are manufactured from low density polyethylene and which are intended to occlude all acetabular dome screw holes not occupied by bone screws. The Osteonics® Screw Hole Plugs will be factory-assembled to every acetabular dome screw hole in the acetabular shell. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw.
The Osteonics® Screw Hole Plugs, by occluding the shell screw holes, will help prevent intrusion of bone cement into the shell and potential migration of debris through open screw holes into the acetabulum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies
Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading.
Key Metrics
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Predicate Device(s)
Osteonics® Omnifit® UHMWPE Acetabular Shell Cement Spacer System, Osteonics® Acetabular Screw Hole Plugs, Osteonics® Universal Cement Plug
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
FEB 28 1997
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Screw Hole Plugs
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|------------------------------------------------------------------|
| Contact Person: | Terry Sheridan
Regulatory Affairs Specialist |
| Date of Summary Preparation: | December 17, 1996 |
| Device Identification | |
Proprietary Name:
Common Name:
.. ... .. .
Classification Name and Reference:
Osteonics® Screw Hole Plugs
Prosthesis, hip, cement restrictor
Surgical mesh 21 CFR §878.3300
Predicate Device Identification
The Osteonics" Screw Hole Plugs are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:
- Osteonics® Omnifit® UHMWPE Acetabular Shell Cement Spacer System, .
- Osteonics® Acetabular Screw Hole Plugs, .
- . Osteonics® Universal Cement Plug
Device Description
The Osteonics® Screw Hole Plugs are small circular plugs which are manufactured from low density polyethylene and which are intended to occlude all acetabular dome screw holes not occupied by bone screws. The Osteonics® Screw Hole Plugs will be factory-assembled to every
1
acetabular dome screw hole in the acetabular shell. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw.
The Osteonics® Screw Hole Plugs, by occluding the shell screw holes, will help prevent intrusion of bone cement into the shell and potential migration of debris through open screw holes into the acetabulum.
Intended Use:
The Osteonics® Screw Hole Plugs are intended to occlude the unused dome screw holes of any Osteonics acetabular shell component. The Osteonics® Screw Hole Plugs will be used either with or without bone cement depending upon the labeled indications of the associated acetabular shell component. The Osteonics® Screw Hole Plugs do not carry their own indications and contraindications, but-as accessories to acetabular shell components -- would be subject to all of the indications and contraindications of the associated acetabular shells.
Statement of Technological Comparison:
The substantial equivalence of the subject devices to the predicate devices, in terms of design, materials, and intended use are discussed below.
Design:
The subject Osteonics® Screw Hole Plugs and the predicate Osteonics® Acetabular Screw Hole Plugs are both circular disks intended to occlude unused screw holes. The subject devices are preassembled to their shells at Osteonics, and may be removed by the surgeon intraoperatively. The predicate devices were not pre-assembled, but instead were assembled to their shells intraoperatively .
Materials
The subject devices are made from low density polyethylene. The predicate cement plug is made from the same low density polyethylene as the subject device. The subject devices have been designed so that they contact neither the acetabular insert nor the acetabular host bone. Because the subject devices are non-load bearing, low density polyethylene is an appropriate material for this application.
Intended Use:
Both the subject Osteonics® Screw Hole Plugs and the predicate Osteonics® Acetabular Screw Hole Plugs are intended to occlude unused screw holes, thus prevential intrusion of bone cement and potential emigration of debris through the shell screw holes into the acetabulum. Both the subject and predicate devices are intended for cementless applications, depending upon the intended use of the associated acetabular shell.
Performance Data:
Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading.