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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: HSX FDA class 2

    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

    Orthopedic

    View full classification →

    A non-constrained, cemented, metal/polymer femorotibial knee prosthesis is a total knee replacement implant that allows unconstrained motion at the joint interface and is fixed to bone using cement, used to treat severe knee arthritis or joint damage. It is classified as an FDA Class 2 device under 21 CFR 888.3520, indicating moderate risk and requiring 510(k) premarket clearance. Product code HSX falls under the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Arthrex iBalance Partial Knee System
    ACTIFY™ Unicondylar Knee System
    JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
    OvertureTi Knee Resurfacing SystemTM
    TRIBRID® Unicompartmental Knee System
    Uni Knee Resurfacing System
    TLC Unicompartmental Knee System
    Restoris Multi-Compartmental Knee System
    Balanced Knee System Uni
    MOTOTM Partial Knee & MOTO PFJ Systems Extension
    BC Reflex Uni Knee System
    VISIONAIRE UK Patient Matched Cutting Guides
    BC Reflex Uni Knee System
    BC Reflex Uni Knee System
    ACS LD Uni FB Knee System
    Triathlon PKR System
    Materialise PKA Guide System
    Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill
    iBalance UKA Tibial Tray Implant
    BC Reflex Uni Knee System
    Bodycad Unicompartmental Knee System
    JOURNEY II Unicompartmental Knee System
    EMPOWR Partial Knee
    Journey II Unicompartmental Knee System
    MOTO Partial Knee System
    Bodycad Unicompartmental Knee System
    Materialise PKA Guide System
    Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
    Materialise PKA Guide System
    Tahoe Uni Knee System
    GMK UNI
    Bodycad Unicompartmental Knee System
    MOTO Partial Knee System
    Arthrex iBalance UKA System Vitamin E Tibial Bearing
    Persona Partial Knee System
    ZUK Select Knee System
    JOURNEY II Uni Tibial Base and Insert
    IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
    STRIDE UNICONDYLAR KNEE
    ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
    CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
    HLS UNI EVOLUTION & U-KNEETEC
    ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
    SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
    CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
    JOURNEY UNICONDYLAR TIBIAL BASEPLATES
    TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
    GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
    MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM
    TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY 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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