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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: GXP FDA class 2

    Methyl Methacrylate For Cranioplasty

    Neurology

    View full classification →

    Methyl Methacrylate for Cranioplasty is a bone cement-like implant material used intraoperatively to reconstruct cranial defects by molding directly to the patient's skull contour and then hardening in place. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and carries an implant designation due to its permanent placement in the body. The product code is GXP under regulation 21 CFR 882.5300 in the Neurology specialty. The implant flag is active for this device.

    510(k) Clearances

    44 matches
    K Number
    Device Name
    Permatage XT Settable Bone Putty
    Permatage Flowable, Settable Bone Paste
    MONTAGE XT Cranial Cement
    Permatage Settable Bone Putty
    Montage Flowable Settable, Resorbable Bone Paste
    MONTAGE-QS Settable, Resorbable Bone Putty
    MONTAGE Settable, Resorbable Bone Putty
    DB-CMF
    OsteoVation Impact
    DirectInject
    NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
    KRYPTONITE BONE CEMENT
    POLYBONE
    OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
    MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
    STRYKER INJECTABLE CEMENT
    NORIAN CRS FAST SET PUTTY
    NORIAN CRS BONE CEMENT
    OSTEOPORE PCL SCAFFOLD
    OSTEOVATION CMF BONE VOID FILLER
    BONE SOURCE HAC RAPID SETTING CEMENT
    VISIOPLAST ACRYLIC RESIN
    MIMIX MP BONE VOID FILLER
    CALLOS CMF BONE VOID FILLER
    SYNTHES (USA) CHRONOS
    BONE CEMENT FOR CRANIOPLASTY
    BONESOURCE HAC FAST SETTING CEMENT
    CAP BONE SUBSTITUTE MATERIAL
    BIOMET CRANIOFACIAL ACRYLIC CEMENT
    CONCERT CRANIOPLAST
    QUICKSET MIMIX BONE VOID FILLER
    BONESOURCE HAC
    FAST SET PUTTY
    DRG QUICKMIX
    MODIFICATION TO: INJECTABLE MIMIX
    PARALLAX CRANIOSET
    CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
    BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
    BSM- BONE SUBSTITUTE MATERIAL
    MEDPOR SURGICAL GRANULE IMPLANTS
    NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
    BONESOURCE HYDROXYAPATITE CEMENT (HAC)
    BONESOURCE HYDROXYAPATITE CEMENT (HAC)
    CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL

    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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