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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: HSN FDA class 2

    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

    Orthopedic

    View full classification →

    A semi-constrained, cemented, metal/polymer ankle prosthesis is a total ankle replacement implant used to restore joint function in patients with end-stage ankle arthritis, consisting of metallic and polymer components fixed with bone cement. It is classified as an FDA Class 2 device under 21 CFR 888.3110, indicating moderate risk and requiring 510(k) premarket clearance. Product code HSN falls under the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Prophecy Incompass Surgical Planning System
    Kinos Total Ankle System
    Incompass Total Ankle System
    APEX 3D Total Ankle Replacement System
    Hintermann Series H2 Total Ankle System
    Prophecy Surgical Planning System
    Kinos Total Ankle System
    Kinos Total Ankle System
    APEX 3D Total Ankle Replacement System
    restor3d Kinos Axiom Total Ankle System
    QUANTUM® Patient Specific Instrumentation (PSI) System
    Kinos Axiom Total Ankle System
    Exactech® Vantage® Total Ankle System
    Vantage® Total Ankle System
    OPTIX H2 Patient Specific Instrument System
    QUANTUM Patient Specific Instrumentation (PSI) System
    Prophecy Preoperative Navigation Alignment System
    MAVEN™ Patient-Specific Instrumentation
    QUANTUM® Patient Specific Instrumentation (PSI) System
    PROPHECY Preoperative Navigation Alignment System
    Apex 3D Total Ankle Replacement System
    Maven Patient-Specific Instrumentation
    APEX 3D Total Ankle Replacement System
    Paragon 28 APEX 3D Total Ankle Replacement System
    Kinos Axiom Total Ankle System
    Cadence Total Ankle System
    The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
    Quantum® Total Ankle Prosthesis
    INFINITY Total Ankle System, INBONE Total Ankle System
    Vantage Total Ankle Flat Cut Talar Components
    Integra Salto Total Ankle System
    INFINITY Total Ankle System
    INVISION Total Ankle Revision System
    INFINITY Total Ankle System
    Hintermann Series H2 Total Ankle System
    INVISION Total Ankle Revision System
    PROPHECY INVISION Pre-operative Navigation System
    PROPHECY INVISION Preoperative Navigation Alignment System
    Salto XT, Salto Talaris
    INVISION Total Ankle Revision System
    Exactech Vantage Total Ankle System
    Integra Total Ankle Replacement System
    INVISION TOTAL ANKLE REVISION SYSTEM
    INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM
    INFINITY TOTAL ANKLE SYSTEM
    INBONE TOTAL ANKLE
    PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
    SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
    INFINITY TOTAL ANKLE SYSTEM
    INBONE ( I AND II) TOTAL ANKLE SYSTEMS

    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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