510(k) Report

Devices descending from K060988

194 later devices reach Total and Hemi Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+5K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+5K141345Aequalis FX2Tornier S.A.S.201411
+5K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+5K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+6K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+6K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+6K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+6K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+6K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+6K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+6K152966Aequalis Fx2Tornier S.A.S.201601
+7K254003JARVIS Metaphyseal StemFH Industrie20260—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K240876Identity Shoulder SystemZimmer, Inc.20241—
+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—
+7K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+7K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+9K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—