510(k) Report

Devices descending from K080402

78 later devices reach Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+1K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+1K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+1K130550RSP Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining ScrewEncore Medical L.P.20140—
+1K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+1K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+1K111629Turon RSP Socket Shell-Neutral Model 508-02-000, Turon RSP Socket Shell-Offset Model…Encore Medical L.P.201140—
+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—
+2K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+2K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+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
+2K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+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—
+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—
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+3K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+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—
+4K243509Archer PSI System3D-Side20250—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+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
+6K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+6K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—