BEUDAMED
    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: JDQ FDA class 2

    Cerclage, Fixation

    Orthopedic

    View full classification →

    Cerclage Fixation devices are orthopedic implants consisting of wire or cable loops placed circumferentially around a bone to hold fracture fragments together or to reinforce periprosthetic fractures and osteotomies. They are classified as FDA Class 2 (moderate risk), subject to general controls and requiring 510(k) premarket notification before marketing. The product code is JDQ, regulated under 21 CFR 888.3010, within the Orthopedic medical specialty. This device is flagged as an implant due to its placement within the body during surgical procedures.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
    Mbrace Cable
    ACCORD Cable System
    VariTrax Sternal CircumFixation System
    Arthrex Radiopaque FiberTape Cerclage sutures
    STRETTO™ Cable System
    HS Fiber Cerclage
    STERN FIX Sternal Stabilization System
    Stern Fix Sternal Stabilization System
    EVOS Cabling System
    Dall-Miles® Cable System
    Sternal Cable System
    Tritium Sternal Cable Plate System
    Thorecon Rigid Fixation System
    Impress SFS System
    SuperCable® Iso-Elastic™ Cerclage System
    DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
    Sternal Cable System
    Thorecon™ Fixation System
    Arthrex FiberTape Cerclage
    Tritium® Sternal Cable Plate System
    KLS Martin LSS Plating System
    Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
    Frontier Medical Devices In-Line Orthopedic Cable Cerclage System
    Frontier Medical Devices In-line Orthopedic Cable Cerclage System
    DSM Biomedical DPR Cable
    Frontier Medical Devices Posterior Cable Screw System
    Suture Wires and Wire Loops
    Tritium Sternal Cable Plate System
    PERI-PROSTHETIC CABLE SYSTEM
    TRITIUM STERNAL CABLE PLATE SYSTEM
    COMPRESSYN BAND
    JAZZ SYSTEM
    SPINAL ELEMENTS CERCLAGE SYSTEM
    PASS LP SPINAL
    SYNTHES STERNAL ZIPFIX SYSTEM
    FIGURE 8 STERNOTOMY CLOSURE DEVICE
    K2M COCR WIRE
    BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
    COMPRESSYN BAND
    ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
    SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS
    UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
    UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
    SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
    BIOMET CABLE SYSTEM
    AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
    ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
    SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
    CABLING SYSTEM TROCHANTER HOOK

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump