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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: MQV FDA class 2

    Filler, Bone Void, Calcium Compound

    Orthopedic

    View full classification →

    The Calcium Compound Bone Void Filler is an orthopedic implant made from calcium-based materials (such as calcium sulfate, calcium phosphate, or hydroxyapatite) used to fill bony defects and voids, supporting bone healing and regeneration. Classified as FDA Class 2 under 21 CFR 888.3045 in the Orthopedic specialty, it requires 510(k) premarket notification. The product code is MQV, and it carries an implant flag.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Device 300419 Strip
    JAZBI™ Resorbable Bone Void Filler
    Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute
    Adaptos®Fuse Bone Graft
    FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute
    Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™
    Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)
    Device 300423 Granules
    OsteoFlo HydroFiber
    Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft
    OsteoFlo HydroFiber
    MagnetOs MIS
    Synthecure Synthetic Calcium Sulfate
    NanoBone® SBX Putty ; NanoBone® QD
    Porous Biologic Scaffold
    BonVie+
    Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
    Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules
    GlassBone Granules
    OsteoFlo HydroFiber
    BioSphere Putty; BioSphere MIS Putty
    EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
    Porous Biologic Scaffold
    MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
    Montage-XT Settable Bone Putty
    Device 300397 Putty
    Citrepore™
    Mg OSTEOREVIVE™, Mg OSTEOCRETE™
    NovaBone Putty - Synthetic Bioactive Bone Graft
    Cove Putty, OsteoCove Putty
    Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips
    Montage-XT Settable, Resorbable Bone Putty
    Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS
    Montage Settable Bone Putty
    MagnetOs Easypack Putty
    Xerosyn
    Morpheus® Moldable; Agilon® Moldable
    MagnetOs Putty
    NuVasive AttraX Scaffold
    Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix
    Synthetic Bone Putty
    Cerament Bone Void Filler
    NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
    ReBOSSIS
    Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™
    MagnetOs Granules
    Tactoset® Injectable Bone Substitute
    MagnetOs Putty
    MagnetOs Easypack Putty
    SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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