510(k) Report

Devices descending from K790987

271 later devices reach Zimmer R Total Shoulder II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980244Aequalis Shoulder ProsthesisTornier1999160—
+1K982981New Zimmer Shoulder SystemZimmer, Inc.19982351
+2K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+2K110791Bigliani / Flatow (R) the Complete Shoulder SolutionZimmer, Inc.201101
+2K111596Total Shoulder SystemShoulder Innovations, LLC201115—
+2K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+2K102670Total Shoulder SystemShoulder Innovations, LLC201118—
+2K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+2K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+2K041549Zimmer Trabecular Metal Humeral StemZimmer, Inc.20042188
+2K030344Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral HeadsSmith & Nephew, Inc.20030—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+3K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+3K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+3K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+3K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110905Total Shoulder SystemShoulder Innovations, LLC20110—
+3K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+3K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+3K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+3K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+3K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+3K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+3K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+3K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+3K050761Zimmer Trabecular Metal Humeral Stem, Sizes 6MM and 8MMZimmer, Inc.200506
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+4K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+4K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+4K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+4K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+4K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+4K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+4K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+4K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+4K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+4K112983Spacer-STecres S.P.A.20117—
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+4K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+4K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+4K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+4K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+4K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+4K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K254003JARVIS Metaphyseal StemFH Industrie20260—
+5K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+5K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+5K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—