LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213342
    Device Name
    PRO-DENSE LoVisc Bone Graft Substitute
    Manufacturer
    Wright Medical Technology, Inc.
    Date Cleared
    2022-01-05

    (90 days)

    Product Code
    MQV,MOV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K181255,K200507
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PRO-DENSE LoVisc™ resultant pastel is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the sketal system (i.e., the extremities, and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

    The PRO-DENSE LoVisc™ paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

    PRO-DENSE LoVisc™ is provided sterile for single use only.

    Device Description

    PRO-DENSE LoVisc™ Bone Graft Substitute is a calcium sulfate formulation consisting of a powder component and aqueous mixing solutions. When the two component types are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.

    AI/ML Overview

    The provided text is a 510(k) summary for the PRO-DENSE LoVisc™ Bone Graft Substitute. It does not describe a study involving an AI device or present acceptance criteria and performance data for such a device. Instead, it focuses on demonstrating substantial equivalence of a medical device (bone graft substitute) to a predicate device based on non-clinical evidence.

    Therefore, I cannot extract the requested information regarding an AI device's acceptance criteria, study details, expert involvement, or ground truth establishment from this document.

    The document states:

    • "SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE: N/A"
    • "Ejection testing and LAL testing demonstrated that subject with increased working time, adjusted fill volumes, and updated kit accessories are equivalent to the predicate."

    This indicates that the equivalence was established through non-clinical testing, not a clinical study involving human readers or AI performance metrics.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1