510(k) Report

Devices descending from K092873

125 later devices reach Reverse Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+1K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+1K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+1K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+1K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+1K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+1K141006RSP Humeral Socket InsertDjo Global2014212
+1K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+1K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+1K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P.2011741
+1K100741Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts…Encore Medical L.P.2010651
+2K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+2K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+2K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+2K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+2K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+2K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+2K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+2K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+2K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+2K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+2K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+2K111061Reverse Shoulder Monoblock Prosthesis (RSP)Encore Medical L.P.201119—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+3K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K201315PERFORM Humeral System – StemTornier, Inc.2020111
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+3K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+4K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K243509Archer PSI System3D-Side20250—
+4K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K254003JARVIS Metaphyseal StemFH Industrie20260—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182