BEUDAMED
    Product Code: KWS FDA class 2 21 CFR 888.3660

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

    Orthopedic

    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.

    View on FDA
    510(k)s
    187
    FEI Numbers
    222
    Registration Numbers
    222
    Unique Applicants
    80
    Years Active
    44

    Basic Information

    Product Code
    KWS
    Device Class
    FDA class 2
    Regulation Number
    888.3660
    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 187 510(k) clearances via K numbers.

    K Number Device Name
    K241292 MyShoulder Planner (5.3SSWPL)
    K241878 Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
    K241609 Tornier Humeral Reconstruction System (Tornier HRS)
    K230513 Arthrex Univers Apex OptiFit Humeral Stem
    K222592 AltiVate® Anatomic Shoulder AG e+™ with Markers
    K230572 AETOS Shoulder System
    K220847 AETOS Shoulder System
    K222317 Catalyst EA Convertible Stemmed Shoulder
    K213387 AltiVate® Anatomic Shoulder AG e+™ with Markers
    K213785 SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
    K213827 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)
    K212356 Exactech® Equinoxe® Laser Cage Glenoid
    K212435 Comprehensive Humeral Fracture Positioning Sleeves
    K210861 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    K210050 Augmented VaultLock Glenoid
    K203315 BLUEPRINT™ Patient Specific Instrumentation
    K203230 Global Shoulder and Delta CTA systems
    K203026 AltiVate® Anatomic Pegged Glenoid with Markers
    K202289 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    K193180 Alliance Augmented Glenoid
    K191247 SmartSPACE Shoulder System
    K191814 Alliance Glenoid
    K190286 Materialise Glenoid Positioning System
    K191318 AEQUALIS FLEX REVIVE Shoulder System
    K190521 Aequalis Ascend Flex Shoulder System
    K190290 AltiVate Reverse Humeral Stem, 48mm
    K182799 Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
    K183039 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    K183042 SMR Lateralized Connectors with screws
    K181555 Arthrex Fracture Adapter Hemi Shoulder Prosthesis
    K181742 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    K181420 Aequalis Flex Revive Shoulder System
    K171841 Arthrex Shoulder System
    K172054 Materialise Glenoid Positioning System
    K172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
    K172210 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    K170910 Medacta Anatomic Shoulder Prosthesis
    K170893 Materialise Glenoid Positioning System
    K162800 BLUEPRINT Patient Specific Instrumentation
    K162697 Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal
    K161789 BLUEPRINT Patient Specific Instrumentation
    K161863 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
    K162024 AltiVate Anatomic Shoulder System
    K161108 Arthrex VaultLock Glenoid
    K160975 Aequalis PerFORM+ Shoulder System
    K160555 BLUEPRINT Patient Specific Instrumentation
    K153602 Materialise Glenoid Positioning System
    K153722 SMR 3-Pegs Glenoids
    K160085 Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
    K153215 SmartBase for Arthrex Glenoid IRIS
    K152047 INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
    K152267 Remedy® Shoulder Spacer
    K153115 Arthrex Univers Apex, Size 5 Stem
    K151500 Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
    K151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
    K143256 SMR Modular Glenoid
    K150583 Aequalis PerFORM+ Shoulder System
    K143374 BLUEPRINT Patient Specific Instrumentation
    K142403 Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
    K142072 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
    K142413 TITAN Modular Total Shoulder System
    K133349 SMR TT METAL BACK GLENOID
    K133834 DEPUY GLOBAL UNITE SHOULDER SYSTEM
    K140063 EQUINOXE EXTRA SHORT HUMERAL HEAD
    K133462 DUOCENTRIC REVERSED SHOULDER PROSTHESIS
    K130048 REVERSE SHOULDER PROSTHESIS MONOBLOCK
    K131633 ARTHREX UNIVERS APEX
    K131559 MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
    K131277 SEVIIN FRACTURE SHOULDER
    K131129 CAS PSI SHOULDER
    K130050 TITAN REVERSE SHOULDER SYSTEM
    K130642 SMR 3-PEGS GLENOIDS
    K131112 LIMACORPORATE SMR CTA HUMERAL HEADS
    K130129 UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
    K123122 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
    K123982 TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
    K122698 AEQUALIS ASCEND FLEX SHOULDER SYSTEM
    K121220 EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
    K121493 ASCEND SHOULDER SYSTEM
    K120794 ASCEND SHOULDER SYSTEM
    K112438 TITAN MODULAR TOTAL SHOULDER SYSTEM
    K113413 ASCEND SHOULDER SYSTEM
    K120044 ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED
    K113012 PROMOS MODULAR SHOULDER SYSTEM
    K113309 EXACTECH EQUINOXE CAGE GLENOIDS
    K111902 AEQUALIS SHOULDER SYSTEM
    K111212 SMR SHOULDER SYSTEM- REVISION STEMS
    K110847 SMR SHOULDER SYSTEM - CTA HUMERAL HEADS
    K111596 TOTAL SHOULDER SYSTEM
    K111379 EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
    K110905 TOTAL SHOULDER SYSTEM
    K103835 REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N
    K110865 AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
    K102924 AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
    K102670 TOTAL SHOULDER SYSTEM
    K103466 ARTHREX UNIVERS II SHOULDER PROSTHESIS
    K103419 EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
    K093599 ARROW ANATOMICAL SHOULDER SYSTEM
    K103104 SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
    K103007 AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
    K093430 EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
    K100448 ASCENSION MODULAR TOTAL SHOULDER SYSTEM
    K091196 GRS GLENOID RESURFACING SYSTEM
    K092122 GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
    K091751 DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
    K083435 ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
    K082120 AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
    K081707 AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
    K081620 MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
    K080402 ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
    K071032 ARTHREX UNIVERS II SHOULDER PROSTHESIS
    K071090 TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
    K060694 MODULAR HYBRID GLENOID
    K060988 TOTAL AND HEMI SHOULDER SYSTEM
    K062029 ANATOMICAL SHOULDER FRACTURE SYSTEM
    K062113 SOLAR REUNION FRACTURE STEM
    K060874 DEPUY GLOBAL AP SHOULDER SYSTEM
    K060209 AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
    K052472 DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
    K051623 ANATOMICAL SHOULDER KEELED GLENOID
    K043346 GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
    K043077 MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM
    K043061 THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
    K042021 EXACTECH EQUINOXE SHOULDER SYSTEM
    K041339 AEQUALIS SHOULDER SYSTEM
    K040610 VERSA-DIAL HUMERAL HEAD
    K033506 COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
    K032679 AEQUALIS SHOULDER FRACTURE SYSTEM
    K031449 MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
    K030259 AMATOMICAL SHOULDER WITH REMOVABLE HEAD
    K030344 MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
    K020345 ARTHREX UNIVERS FRACTURE PROSTHESIS
    K012788 VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II
    K012378 3D HUMERAL HEADS
    K003324 PLASMA SPRAYED SHOULDER
    K012212 MODIFICATION TO AEQUALIS SHOULDER SYSTEM
    K010124 ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
    K003801 ANATOMICAL PRESS-FIT HUMERAL STEM
    K003566 COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
    K003832 SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM
    K003728 MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
    K002683 WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
    K001706 WMT MODULAR SHOULDER SYSTEM
    K994393 AEQUALIS UNIVERSAL SHOULDER GLENOID
    K001046 BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
    K994350 NEER III TOTAL SHOULDER SYSTEM
    K994392 AEQUALIS SHOULDER FRACTURE SYSTEM
    K000575 GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
    K992899 BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
    K992119 BIO-MODULAR SHOULDER SYSTEM
    K980244 AEQUALIS SHOULDER PROSTHESIS
    K992065 GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD
    K990598 OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
    K990136 ANATOMICA GLENOID COMPONENT
    K990137 ANATOMICA HUMERAL STEM/HEAD COMPONENTS
    K981487 DEPUY GLOBAL SHOULDER GLENOID
    K974044 GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
    K971715 SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
    K962224 SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
    K962082 OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
    K960906 FOUNDATION GLENOID COMPONENT
    K955944 OSTEONICS N2/VAC PACKAGING PROCESS
    K955767 COFIED MODULAR SHOULDER SYSTEM
    K955731 OSTEONICS SHOULDER HUMERAL COMPONENTS
    K952928 AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS
    K950521 OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
    K950651 TOTAL SHOULDER PROSTHESIS
    K935802 SELECT(R) SHOULDER ALL POLY GLENOID
    K943300 DEPUY POROUS COATED GLOBAL SHOULDER
    K920362 3M MODULAR SHOULDER SYSTEM
    K904880 BUECHEL-PAPPAS HUMERAL STEM COMPONENT
    K904879 BEUCHEL-PAPPAS GLENOID COMPONENT
    K903886 OSTEONICS SR GLENOID COMPONENTS
    K902855 NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT
    K901434 PAPILLOTOME
    K895226 NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS
    K884943 INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID
    K883816 SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
    K881750 NORMAL HUMERAL PROSTHESIS
    K881836 INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP
    K870262 FENLIN II SHOULDER PROSTHESIS
    K862535 OSTEONICS SHOULDER PROSTHESIS
    K855183 COFIELD SHOULDER SYSTEM
    K852365 LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM
    K843624 COFIELD SHOULDER SYSTEM
    K833410 MONOSPHERICAL GLENOID PROSTH. KEEL
    K801970 UCLA SHOULDER

    FEI Numbers

    This FDA classification entry is associated with 222 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 222 registration numbers. Click on an entry to view related FDA registrations.