510(k) Report

Devices descending from K940537

281 later devices reach Kirschner (R) Modular II-C (TM) Total Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+6K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+6K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+6K193175Lateralized GlenosphereMedacta Inernational SA20201—
+6K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+6K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+6K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+6K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+6K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+6K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+6K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+6K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+6K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+6K141345Aequalis FX2Tornier S.A.S.201411
+6K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K141006RSP Humeral Socket InsertDjo Global2014212
+6K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+6K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+6K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+6K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+6K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+7K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+7K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+7K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+7K201315PERFORM Humeral System – StemTornier, Inc.2020111
+7K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+7K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+7K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+7K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+7K152966Aequalis Fx2Tornier S.A.S.201601
+7K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+8K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+8K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+8K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+8K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+8K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+8K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+9K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+9K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+10K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+10K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—