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510(k) Data Aggregation

    K Number
    K252085
    Date Cleared
    2025-09-30

    (90 days)

    Product Code
    Regulation Number
    888.3045
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Allomatrix® Injectable Putty, Allomatrix C, and Allomatrix® DR products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Allomatrix® products are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

    AlloMatrix® Custom Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of bony structure. AlloMatrix® Custom Putty is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine), and as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

    Device Description

    The Allomatrix® family of bone void fillers are comprised of demineralized bone matrix (DBM), a range of cancellous bone matrix (CBM) granules, and a binder of surgical-grade calcium sulfate and carboxymethylcellulose (CMC). Allomatrix® is available in four formulations and various volumes to accommodate surgeon needs. After mixing, the resultant putty can then be handled and placed in the appropriate bone voids.

    AI/ML Overview

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