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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: MQP FDA class 2

    Spinal Vertebral Body Replacement Device

    Orthopedic

    View full classification →

    The Spinal Vertebral Body Replacement Device is an orthopedic implant used to replace one or more vertebral bodies following trauma, tumor resection, or infection, restoring spinal column height and stability. Classified as FDA Class 2 under 21 CFR 888.3060 in the Orthopedic specialty, it requires 510(k) premarket notification. The product code is MQP, and it carries an implant flag.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Vertiwedge® Intraosseous System
    KONG®-TL VBR System and KONG® C VBR System
    DOMINION Expandable Corpectomy System
    VerteLoc Spinal System
    Ascend VBR System, Ascend NanoTec VBR System
    ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
    F3D Corpectomy System
    KONG-TL VBR System, KONG-C VBR System
    NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System
    Small VBR™
    MediExpand TL Expandable VBR System
    CarboClear VBR System
    SYNMESH System
    COLOSSEUM Mesh
    PYRAMESH™ Implant System
    Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
    T2 STRATOSPHERE Expandable Corpectomy System
    SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
    Solidity Vertebral Body Replacement
    T2 STRATOSPHERE™ Expandable Corpectomy System
    FORTIFY Corpectomy Spacers
    X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
    Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
    Blustone Synergy Silica System
    T2 STRATOSPHERE™ Expandable Corpectomy System
    FORTIFY Corpectomy Spacers
    Omnia Medical VBR
    Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
    CAPRI Corpectomy Cage System
    VerteFIT Corpectomy Cage System
    CAPRI Corpectomy Cage System
    NuVasive(r) Monolith Corpectomy System
    Rectangular Corpectomy Cage
    NuVasive PEEK Corpectomy Railed System
    NuVasive PEEK Corpectomy System
    SpineFab Vertebral Body Replacement (VBR) System
    NuVasive X-CORE(R) Expandable VBR System
    StaXx(R) XD System
    VERTA Corpectomy Cage
    STGC-LORDOTIC
    CAPRI
    AIS MODULIFT VBR SYSTEM
    LATERAL VBR SYSTEM
    AIS MODULIFT VBR SYSTEM
    TASMIN R
    PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
    STAXX(R) SYSTEM
    T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
    ENDURAMESH
    STAXX XD SYSTEM

    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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