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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: KWT FDA class 2

    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

    Orthopedic

    View full classification →

    The Non-Constrained Metal/Polymer Cemented Shoulder Prosthesis is an orthopedic implant used to replace the glenohumeral joint with a cemented metal-on-polymer articulation that places no inherent constraint on joint motion, relying entirely on the surrounding musculature and soft tissue for stability. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWT, regulated under 21 CFR 888.3650, in the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AGILON® XO Shoulder Replacement System
    InSet Total Shoulder System
    AGILON® XO Shoulder Replacement System
    Comprehensive Segmental Revision System(SRS)
    AGILON XO Shoulder System
    LINK Embrace Shoulder System- Anatomical Configuration
    TiN Coated Humeral Head
    Shoulder Innovations Total Shoulder System
    Catalyst OrthoScience CSR Shoulder System
    Signature ONE System
    Catalyst CSR Press-Fit Humeral Components
    Catalyst CSR Shoulder System
    Catalyst CSR 3 Peg Glenoids
    Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
    SMR Shoulder System
    Catalyst CSR Shoulder System
    Zimmer PSI Shoulder System
    Equinoxe Mega Prosthesis
    HUMELOCK II CEMENTED SHOULDER SYSTEM
    HUMELOCK II CEMENTED SHOULDER SYSTEM
    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
    COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
    BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
    EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
    ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
    LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,
    LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
    NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM
    ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
    DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
    MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD
    ZIMMER TRABECULAR METAL HUMERAL STEM
    INTERLOK BIO-MODULAR HUMERAL STEMS
    BIO-MODULAR SHOULDER SYSTEM
    COMPREHENSIVE HUMERAL FRACTURE SYSTEM
    THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306
    SHORT AND LONG SOFT TISSUE ATTACHMENT
    3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
    EPOCA CODR STEM AND HEAD
    EPOCA CUSTOM OFFSET SHOULDER SYSTEM
    BIOMET BI-POLAR SHOULDER SYSTEM
    BIPOLAR SHOULDER PROSTHESIS
    GRIT BLASTED HUMERAL STEM
    GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
    NEW ZIMMER SHOULDER SYSTEM
    SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
    SELECT SHOULDER COCR HUMERAL STEM COMPONENT
    BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
    SELECT SHOULDER PEGGED ALL-POLY GLENOID
    SELECT SHOULDER KEELED ALL-POLY GLENOIDS

    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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