510(k) Report

Devices descending from K991585

414 later devices reach Bipolar Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+3K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+3K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+3K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+3K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+3K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+3K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+3K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+3K122442Depuy Cta Reverse Shoulder SystemDepuy France20121—
+3K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+3K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+3K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.201171
+3K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+3K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+3K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+3K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+3K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+3K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+3K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+3K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+3K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+3K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+3K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+3K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+3K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+3K070565Cofield Total Shoulder SystemSmith & Nephew, Inc.200726—
+3K060694Modular Hybrid GlenoidBiomet Manufacturing Corp2006574
+3K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.200621
+3K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+3K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20061386
+3K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+3K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc.20051761
+3K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp20059—
+3K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417—
+3K033516Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc.2003135—
+3K032895BI-Angular Shoulder SystemBiomet, Inc.200310—
+4K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+4K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241470CORE Shoulder SystemLinkBio Corp.202501
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+4K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+4K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—