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: JWH FDA class 2

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

    Orthopedic

    View full classification →

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer is a total knee replacement implant that resurfaces the patellofemoral and tibial articulating surfaces using a semi-constrained design, cemented in place, with polymer bearing components on a metal tray. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is JWH, regulated under 21 CFR 888.3560, and falls within the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    NovoKnee (SteriKnee)
    Materialise TKA Guide System
    EMPOWR Knee
    ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors
    Freedom Infinia™ Total Knee System
    Freedom® Total Knee System – Titan PCK Components
    Stem Extension Line (U2 Total Knee System—PSA Type)
    Materialise TKA Guide System
    EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)
    EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)
    Freedom® Total Knee System – Titanium Tibial Base Plate
    NextStep Arthropedix Total Knee System
    EXULT Knee Replacement System
    LEGION Total Knee System
    Klassic Knee System - Revision Tibial Baseplate
    Freedom Total Knee System (All-poly Tibial Plate)
    Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)
    MedalOne Total Knee System
    Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
    Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert
    Consensus Knee System with TiNbN
    Initia Knee System
    Cellbrick Knee Spacer
    Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System
    Freedom® Medial Congruent Liner
    BKS Revision System
    REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component
    Unity Total Knee System
    EXULT Knee Replacement System
    Rx Knee System
    ACS® LD FB Knee System
    EXULT Knee Replacement System
    ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;
    Freedom® Total Knee System
    UNIKO PointCloud™ Knee Instruments
    Unity Knee PS-C Tibial Insert
    ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System
    EMPOWR Revision Symmetric Knee Cones
    KeYi Total Knee System
    XN Knee Prosthesis System
    AMF TT Cones
    PNK Total Knee System
    TRAX® CR Total Knee System
    EVOLUTION® Cement Keel
    Balanced Knee® System TriMax PS Plus Tibial Insert
    Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post
    TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
    iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
    MyKnee UNI-ST
    Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component

    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