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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: HSZ FDA class 1

    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

    General, Plastic Surgery

    View full classification →

    A pneumatic-powered orthopedic surgical instrument and accessory/attachment is a pneumatically driven tool used in orthopedic surgery for tasks such as drilling, reaming, sawing, or driving implants, along with its associated accessories. It is classified as an FDA Class 1 device under 21 CFR 878.4820, indicating low risk and general controls only. Product code HSZ falls under the General and Plastic Surgery medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    EMS SWISS ORTHOCLAST
    CURVTEK TSR SYSTEM
    ALIGNMENT INSTRUMENT
    ASPACH 65,000 (MODIFICATION)
    SODEM HIGH SPEED SYSTEM
    ETHICON DRILL BIT AND DRILL GUIDE
    SPINALPLANE
    FILTER, DIFFUSER
    PNEUMATIC WIRE TENSIONER
    ARTHREX CIRCULAR HARVESTING SAW
    TAVA WIRE-DRIVER
    PNEUMATIC WIRE TENSIONER
    THE DE SOUTTER M193 REAMER
    THE DE SOUTTER M182 DRILL
    MEDNEXT 1000 BONE DISSECTING SYSTEM
    HHI PNEUMATIC ROTARY DRILL
    MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE
    M170 PNEUMATICALLY OPERATED OSCILLATING SAW
    JOHNSON AND JOHNSON POWER SYSTEM
    OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR
    CUP OUT
    MICRO-AIRE 4220-000 OSCILLATING SAW
    BONE RASPS
    A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
    OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
    THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM
    BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
    MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS
    INTERMEDICS POWER BROACH IMPACTOR
    MICRO SURGICAL INSTRUMENT SYSTEM
    MICRO SURGICAL INSTRUMENT SYSTEM
    CONCEPT POWER SYSTEM
    ARTUS DISPOSABLE SHEATHS/CUTTERS
    ACE PNEUMATIC OSCILLATING SAW
    RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS
    MICRO-AIRE CEMENT REMOVAL TOOLS
    1.1 COUPLERS AND 1.2 ADAPTERS
    KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER
    ORTHOPEDIC DRILL GUIDE
    EFTEKHAR RECHANNELIZATION DRILL GUIDE
    REPLACEMENT HOSES
    MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER
    ACUFEX ARTHROSCOPIC SHAVER
    NUCLEOTOME
    ENDOTOME PNEUMATIC ORTHOPAEDIC CUT
    ANSPACH 65,000
    MICRO OSCILLATING SAW
    CORB TM COUNTERROTATING BIOPSY NEEDLE
    OSTEO OSCILAIR
    ANSPACH INSTRUMENT CADDY

    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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