(66 days)
Osteonics® Omnifit® Total Knee System Screw Hole Plugs, Osteonics® Universal Cement Plug
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No
The device description and intended use clearly define a simple mechanical accessory (screw hole plugs) made of LDPE, with no mention of any computational or data-driven capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as screw hole plugs for tibial tray components, intended to occlude unused screw holes and prevent cement intrusion. It acts as an accessory to another device. It does not directly fulfil a therapeutic purpose.
No
The device description indicates that the plugs are used to occlude unused screw holes in a tibial tray during surgery to prevent cement intrusion, not to diagnose any condition.
No
The device description explicitly states the plugs are manufactured from low density polyethylene (LDPE), indicating a physical 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® Tibial Tray Screw Hole Plugs are physical components used in orthopedic surgery to occlude screw holes in a tibial tray implant. They are part of a surgical procedure and interact directly with the implant and bone cement, not with bodily samples for diagnostic purposes.
- Intended Use: The intended use is to prevent bone cement intrusion during surgery, which is a mechanical function related to the implant procedure, not a diagnostic test.
The description clearly indicates a surgical implant accessory, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Osteonics® Tibial Tray Screw Hole Plugs are intended to occlude the unused tibial screw holes of any Osteonics tibial tray component. The Osteonics® Tibial Tray Screw Hole Plugs will be used with bone cement. The Osteonics® Tibial Tray Screw Hole Plugs do not carry their own indications and contraindications, but -- as accessories to tibial tray components -- would be subject to all of the indications and contraindications of the associated tibial trays.
Product codes
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Device Description
The Osteonics® Tibial Tray Screw Hole Plugs are small circular plugs which are manufactured from low density polyethylene (LDPE) and which are intended to occlude all tibial tray screw holes not occupied by bone screws. The Osteonics® Tibial Tray Screw Hole Plugs will be factory-assembled into every tibial tray hole. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw.
The Osteonics® Tibial Tray Screw Hole Plugs, by occluding the tibial tray screw holes, will help prevent intrusion of bone cement onto the surface of the tibial tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Osteonics® Omnifit® Total Knee System Screw Hole Plugs, Osteonics® Universal Cement Plug
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAY - 9 1997
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics" Tibial Tray Screw Hole Plugs
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
Date of Summary Preparation:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Kate Sutton Regulatory Affairs Specialist
March 3, 1997
Osteonics Tibial Tray Screw Hole Plugs
Tibial tray screw hole plugs
Surgical mesh 21 CFR §878.3300
Predicate Device Identification
The Osteonics" Tibial Tray 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® Total Knee System Screw Hole Plugs .
- Osteonics® Universal Cement Plug .
Device Description
The Osteonics® Tibial Tray Screw Hole Plugs are small circular plugs which are manufactured from low density polyethylene (LDPE) and which are intended to occlude all tibial tray screw holes not occupied by bone screws. The Osteonics® Tibial Tray Screw Hole Plugs will be
1
factory-assembled into every tibial tray hole. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw.
The Osteonics® Tibial Tray Screw Hole Plugs, by occluding the tibial tray screw holes, will help prevent intrusion of bone cement onto the surface of the tibial tray.
Intended Use:
The Osteonics® Tibial Tray Screw Hole Plugs are intended to occlude the unused tibial screw holes of any Osteonics tibial tray component. The Osteonics® Tibial Tray Screw Hole Plugs will be used with bone cement. The Osteonics® Tibial Tray Screw Hole Plugs do not carry their own indications and contraindications, but -- as accessories to tibial tray components -- would be subject to all of the indications and contraindications of the associated tibial trays.
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® Tibial Tray Screw Hole Plugs and the UHMWPE screw hole plugs discussed in the predicate 510(k) are both circular disks intended to occlude unused screw holes. The subject devices are pre-assembled to their tibial trays at Osteonics, and may be removed by the surgeon intraoperatively.
Materials
The subject devices are made from low density polyethylene (LDPE). This material was chosen for its successful clinically demonstrated history of use, as well as its ability to be injection molded. The predicate cement plug is made from the same low density polyethylene as the subject Because the subject devices are non-load bearing, low density polyethylene is an device. appropriate material for this application.
Intended Use:
Both the subject Osteonics® Tibial Tray Screw Hole Plugs and the UHMWPE tibial tray screw hole plugs of the predicate Omnifit® Total Knee System are intended to occlude unused screw holes, thus preventing potential intrusion of bone cement.
The subject and predicate devices are intended for cemented applications only.
Performance Data:
Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading.