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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: KWS FDA class 2

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

    Orthopedic

    View full classification →

    The Semi-Constrained Metal/Polymer Cemented Shoulder Prosthesis is an orthopedic implant that replaces the shoulder joint with a partially constrained metal-on-polymer articulation fixed with bone cement, designed to restore shoulder function in patients with severe glenohumeral joint disease while partially relying on soft tissue for stability. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is KWS, regulated under 21 CFR 888.3660, in the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MyShoulder Planner (5.3SSWPL)
    Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
    Tornier Humeral Reconstruction System (Tornier HRS)
    Arthrex Univers Apex OptiFit Humeral Stem
    AltiVate® Anatomic Shoulder AG e+™ with Markers
    AETOS Shoulder System
    AETOS Shoulder System
    Catalyst EA Convertible Stemmed Shoulder
    AltiVate® Anatomic Shoulder AG e+™ with Markers
    SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
    TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)
    Exactech® Equinoxe® Laser Cage Glenoid
    Comprehensive Humeral Fracture Positioning Sleeves
    ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    Augmented VaultLock Glenoid
    BLUEPRINT™ Patient Specific Instrumentation
    Global Shoulder and Delta CTA systems
    AltiVate® Anatomic Pegged Glenoid with Markers
    ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    Alliance Augmented Glenoid
    SmartSPACE Shoulder System
    Alliance Glenoid
    Materialise Glenoid Positioning System
    AEQUALIS FLEX REVIVE Shoulder System
    Aequalis Ascend Flex Shoulder System
    AltiVate Reverse Humeral Stem, 48mm
    Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
    ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    SMR Lateralized Connectors with screws
    Arthrex Fracture Adapter Hemi Shoulder Prosthesis
    ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    Aequalis Flex Revive Shoulder System
    Arthrex Shoulder System
    Materialise Glenoid Positioning System
    AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
    ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    Medacta Anatomic Shoulder Prosthesis
    Materialise Glenoid Positioning System
    BLUEPRINT Patient Specific Instrumentation
    Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal
    BLUEPRINT Patient Specific Instrumentation
    ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
    AltiVate Anatomic Shoulder System
    Arthrex VaultLock Glenoid
    BLUEPRINT Patient Specific Instrumentation
    Aequalis PerFORM+ Shoulder System
    Materialise Glenoid Positioning System
    SMR 3-Pegs Glenoids
    Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
    SmartBase for Arthrex Glenoid IRIS

    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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