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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: JDS FDA class 2

    Nail, Fixation, Bone

    Orthopedic

    View full classification →

    A Bone Fixation Nail is an intramedullary implant inserted into the medullary canal of a long bone to stabilize and align fractures, particularly of the femur, tibia, or humerus. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification demonstrating substantial equivalence. The product code is JDS, regulated under 21 CFR 888.3030, within the Orthopedic medical specialty. This device is designated as an implant given its internal placement within the bone.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TRIGEN Stable Lock Nut & Washer
    TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System
    TRIGEN INTERTAN 10S Nail System
    NET BRAND Osteosynthesis Nailing System
    TRIGEN META-NAIL Nail System
    DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
    Auxein Nailing System
    WIN Flexible Nail System
    CONVENTUS PHS SYSTEM
    CHINA NAILS AND ACCESSORIES
    SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
    CONNEXX LOCKING TIBIA NAIL
    SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
    SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM
    KNEE FUSION NAIL
    TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
    TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS
    KNEE FUSION NAIL
    SYNTHES (USA) TIBIAL NAIL SYSTEM EX
    TRIGEN INTERTAN
    SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
    NORMED COMPRESSION BONE SCREW SYSTEM
    BNF
    ODI TALON INTRAMEDULLARY HIP NAIL
    BAUMER LOCKING NAIL
    FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
    MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
    WUJIN #3 TIBIAL NAIL
    SYNTHES PROXIMAL HUMERAL NAIL
    PEDIATRIC FIXATION RODS
    ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
    SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
    MACMED PAEDIATRIC INTRAMEDULLARY NAIL
    EUCLID REDUCTION AND GUIDANCE SYSTEM
    INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
    TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
    SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
    TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
    BONE FIXATION NAIL
    SMALL FRAGMENT PLATES AND SCREWS
    HAIG NAIL
    FEMORAL INTRAMEDULLARY RODS
    SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS
    UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
    UNIVERSAL FEMORAL NAIL
    HUMERAL LOCKING NAIL SYSTEM
    TRACER HIP PINNING SYSTEM
    POLY PLUG CEMENT RESTRICTOR
    INTRAMEDULLARY BONE PLUG
    SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)

    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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