510(k) Report

Devices descending from K112069

74 later devices reach RSP Glenoid Baseplate Porous Coated through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+1K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+1K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+1K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+2K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.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—
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+2K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K201315PERFORM Humeral System – StemTornier, Inc.2020111
+3K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+3K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K254003JARVIS Metaphyseal StemFH Industrie20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+5K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K243248Inhance Intact™Depuy Ireland UC20240—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+7K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+7K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—