510(k) Report

Devices descending from K911686

436 later devices reach Global Total Shoulder, Uncement Humeral Hemi-Shoul through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122442Depuy Cta Reverse Shoulder SystemDepuy France20121—
+4K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K120794Ascend Shoulder SystemTornier, Inc.201298—
+4K112983Spacer-STecres S.P.A.20117—
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+4K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+4K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+4K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+4K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+4K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+4K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+4K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+4K071948Aequalis Reversed AdapterTornier2007178—
+4K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+4K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+4K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K243248Inhance Intact™Depuy Ireland UC20240—
+5K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+5K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K213856Identity Shoulder SystemZimmer, Inc.20224—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+5K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+5K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K202338SpaceFlex ShoulderG21, S.R.L.20211—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K192967Medacta Shoulder SystemMedacta International S.A.20200—
+5K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+5K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+5K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+5K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+5K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+5K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+5K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+5K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+5K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—