BEUDAMED
    Product Code: KWT FDA class 2 21 CFR 888.3650

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

    Orthopedic

    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.

    View on FDA
    510(k)s
    69
    FEI Numbers
    158
    Registration Numbers
    158
    Unique Applicants
    36
    Years Active
    46

    Basic Information

    Product Code
    KWT
    Device Class
    FDA class 2
    Regulation Number
    888.3650
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 69 510(k) clearances via K numbers.

    K Number Device Name
    K241944 AGILON® XO Shoulder Replacement System
    K241817 InSet Total Shoulder System
    K231657 AGILON® XO Shoulder Replacement System
    K223631 Comprehensive Segmental Revision System(SRS)
    K222482 AGILON XO Shoulder System
    K210899 LINK Embrace Shoulder System- Anatomical Configuration
    K191698 TiN Coated Humeral Head
    K192365 Shoulder Innovations Total Shoulder System
    K191811 Catalyst OrthoScience CSR Shoulder System
    K190595 Signature ONE System
    K182500 Catalyst CSR Press-Fit Humeral Components
    K181287 Catalyst CSR Shoulder System
    K173812 Catalyst CSR 3 Peg Glenoids
    K162903 Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
    K161476 SMR Shoulder System
    K152825 Catalyst CSR Shoulder System
    K150730 Zimmer PSI Shoulder System
    K143659 Equinoxe Mega Prosthesis
    K140071 HUMELOCK II CEMENTED SHOULDER SYSTEM
    K123814 HUMELOCK II CEMENTED SHOULDER SYSTEM
    K121543 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
    K111746 COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
    K110791 BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
    K110706 EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
    K103404 ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
    K101263 LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,
    K100858 LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
    K071147 NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM
    K050761 ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
    K043505 DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
    K042321 MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD
    K041549 ZIMMER TRABECULAR METAL HUMERAL STEM
    K032507 INTERLOK BIO-MODULAR HUMERAL STEMS
    K030710 BIO-MODULAR SHOULDER SYSTEM
    K023063 COMPREHENSIVE HUMERAL FRACTURE SYSTEM
    K022377 THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306
    K022079 SHORT AND LONG SOFT TISSUE ATTACHMENT
    K020045 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
    K014049 EPOCA CODR STEM AND HEAD
    K010869 EPOCA CUSTOM OFFSET SHOULDER SYSTEM
    K002998 BIOMET BI-POLAR SHOULDER SYSTEM
    K991585 BIPOLAR SHOULDER PROSTHESIS
    K991603 GRIT BLASTED HUMERAL STEM
    K984541 GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
    K982981 NEW ZIMMER SHOULDER SYSTEM
    K970567 SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
    K962315 SELECT SHOULDER COCR HUMERAL STEM COMPONENT
    K960424 BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
    K962244 SELECT SHOULDER PEGGED ALL-POLY GLENOID
    K962238 SELECT SHOULDER KEELED ALL-POLY GLENOIDS
    K961571 COCR BI-ANGULAR HUMERAL COMPONENT
    K940537 KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
    K925613 PROXIMAL HUMERAL REPLACEMENT SYSTEM
    K931114 SELECT(R) SHOULDER ALL-POLY GLENOID
    K922865 NEER TYPE SHOULDER PROSTHESIS SYSTEM
    K915596 BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
    K914695 GLOBAL TOTAL SHOULDER
    K914000 GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE
    K905786 GLOBAL TOTAL SHOULDER
    K895802 NON CONSTRAINED TOTAL SHOULDER SYSTEM
    K873621 NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS
    K873620 NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.
    K873104 NEER-III GLENOID RESURFACING PROSTHESIS
    K872454 BIOMET MODULAR SHOULDER PROSTHESIS
    K833409 MONOSPHERICAL RESURFACING GLENOID PROS
    K831233 GLENOID RESURFACING COMPONENT-3M-10816
    K831234 GLENOID RESURFACE COMPONENT PMN 3M
    K802124 GRISTINA GLENOID PROSTHESIS
    K790987 ZIMMER R TOTAL SHOULDER II

    FEI Numbers

    This FDA classification entry is associated with 158 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 158 registration numbers. Click on an entry to view related FDA registrations.