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510(k) Data Aggregation

    K Number
    K253524

    Validate with FDA (Live)

    Device Name
    Adaptos®Fuse Bone Graft
    Manufacturer
    Biomendex OY
    Date Cleared
    2026-02-17

    (96 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K240404,K071046,K043045,K203714,K222276
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Adaptos®Fuse Bone Graft is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone (i.e., posterolateral spine, intervertebral disc space, and pelvis). In interbody fusion procedures, Adaptos®Fuse Bone Graft must be used with interbody fusion devices FDA cleared for use with bone void filler. Adaptos®Fuse Bone Graft Granules must be mixed with autograft prior to use. Following placement in the bony void or gap, Adaptos®Fuse Bone Graft are resorbed and replaced with bone during the healing process.

    Device Description

    Adaptos®Fuse bone graft device is a bioactive bone void filler provided to the user as granules in open-bore syringes. The granules are made of poly(L-lactide-co-ε-caprolactone) (PLCL), tricalcium phosphate (TCP), and bioactive glass.

    AI/ML Overview

    N/A

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