510(k) Report

Devices descending from K140904

55 later devices reach RSP Monoblock Stem with P2 Coating, Size 6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+1K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+1K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+2K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+2K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+2K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+2K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+2K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+2K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+2K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+2K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+2K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+2K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+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—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+3K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+3K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K201315PERFORM Humeral System – StemTornier, Inc.2020111
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+4K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501