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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: LZK FDA class 2

    Implant, Malar

    General, Plastic Surgery

    View full classification →

    The Malar Implant (product code LZK) is a surgically placed device used to augment the cheekbone (malar) region of the face for cosmetic or reconstructive purposes, restoring facial contour following trauma or providing aesthetic enhancement. Regulated under 21 CFR 878.3550 and classified as a Class 2 device, it requires a 510(k) premarket notification and is flagged as an implant. The device falls under the General and Plastic Surgery specialty. It is not life-sustaining.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    AART MALAR IMPLANT
    IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
    PILLAR MALAR IMPLANT
    SURGIFORM ANATOMICAL MALAR
    SEARE BIOMEDICAL MALAR IMPLANTS
    SILIMED MALAR IMPLANT
    SPECTRUM DESIGNS MEDIAL MALAR IMPLANT
    SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
    SPECTRUM DESIGNS PROFILE MALAR IMPLANT
    IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
    DURALASTIC ANATOMICAL MALAR IMPLANT
    DURALASTIC ANATOMICAL MALAR IMPLANTS
    BONE SOURCE HYDROXYAPATITE
    SURGIFORM ANATOMICAL MALAR
    IMPLANTECH WM NASAL-LABIAL IMPLANT
    HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
    SAM FACIAL IMPLANT
    MEDIAL MALAR IMPLANT
    PERMAMESH HYDROXYLAPATITE MATRIX
    PERMAMESH-D HYDROXYLAPATITE MATRIX
    IMPLANTECH NASAL LABIAL IMPLANT
    SILHOUETTE MALAR IMPLANT
    DORSAL COLUMELLA IMPLANT
    MENISCUS CHIN IMPLANT
    IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT
    IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT
    ZARA ZONE IV MALAR IMPLANT MODIFICATION
    FLOWERS MEDIAL MALAR IMPLANT
    ZARA ZONE IV MALAR IMPLANT
    TRAPEZOIDAL MALAR IMPLANT
    EXTENDED MALAR IMPLANT
    COMBINED MALAR IMPLANT
    CUI FEATHERED SILICONE MALAR
    ZYMALAR IMPLANT
    CUI ANATOMICAL SILICONE MALAR
    ANATOMICAL MALAR IMPLANT
    BINDER SUBMALAR FACIAL IMPLANT II
    BINDER SUBMALAR FACIAL IMPLANT
    CREAT BRAND MALAR IMPLANT
    BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR

    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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