510(k) Report

Devices descending from K914000

235 later devices reach Global (TM) Total Shoulder W/Dupont Enhanced Uhmwpe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+5K163669Humeris ShoulderFx Solutions201720—
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+5K162455Humelock Reversed ShoulderFx Solutions201717—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+5K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+5K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+5K150730Zimmer PSI Shoulder SystemZimmer201511—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+6K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+6K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+6K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+6K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+6K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+6K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+6K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+6K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—
+6K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+6K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+6K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+6K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+6K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+6K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+6K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+6K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K141345Aequalis FX2Tornier S.A.S.201411
+6K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+6K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+7K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+7K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+7K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+7K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+7K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+7K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+7K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+7K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+7K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+7K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+7K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+7K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+7K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+7K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+7K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+7K201315PERFORM Humeral System – StemTornier, Inc.2020111
+7K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+7K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+7K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+7K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+7K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—