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510(k) Data Aggregation

    K Number
    K960914
    Device Name
    3I OSSEOUS FIXATION SYSTEM(S)
    Manufacturer
    IMPLANT INNOVATIONS, INC.
    Date Cleared
    1996-04-04

    (29 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K952811,K952812,K953386,K955369,K952167
    Why did this record match?
    Reference Devices :

    K952811, K952812, K953386

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NEW INDICATION FOR USE: NON-RESORBABLE MEMBRANE FIXATION FOR ENDOSSEOUS DENTAL IMPLANT AND/OR GUIDED TISSUE REGENERATION PROCEDURES, USING OSSEOUS FIXATION (PLATE AND SCREW) SYSTEMS.

    In GBR procedures to form and/or secure a GBR framework, and/or to secure Non-resorbable membranes to the bone, to minimize micro-movement, repress and prevent bacteria and soft tissue (epithelial) in-growth and to permit greater ease in removal of the membrane and framework.

    Device Description

    Bone Plate and/or Intraosseous Fixation Screw or Wire.
    Bone Plates and Screws, Osseous Fixation Systems.
    3i Osseous Fixation System(s).
    Bone Fixation System, Stain Steel - K952811 (SE 08/30/95)
    Bone Fixation System, Co-Cr Alloy - K952812 (SE 08/30/95)
    Bone Fixation System, Titanium - K953386 (SE 09/15/95)

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (3i Osseous Fixation System) and describes a new indication for use. It outlines the regulatory classification, existing and proposed indications, and potential risks, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

    The document is a regulatory submission for a change in the intended use of a device, essentially expanding its application. It focuses on demonstrating "substantial equivalence" to other marketed devices for the new indication, rather than presenting a performance study with acceptance criteria.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance: This information is not present.
    2. Sample sizes, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, or how ground truth for the training set was established: These details would typically be found in a clinical study report or a performance validation study, which is not included in this 510(k) summary.

    The document primarily states that the new indication is based on widespread, clinically accepted GBR procedures using similar systems and references published literature (Buser et al., Meltzer & Edenbaum, Gore Regenerative Technologies, Ultimatics, Inc.) to support the biological rationale and common practice of GBR. It explicitly mentions "substantial equivalence" to other devices like the Straumann USA "Memfix" and IMZ/Interpore Bone Tack System. This means the regulatory pathway is based on the device being similar enough to already approved devices, rather than requiring new performance studies against specific criteria for this new indication.

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