510(k) Report

Devices descending from K023063

146 later devices reach Comprehensive Humeral Fracture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+1K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+1K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20061386
+1K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417—
+1K033506Comprehensive Humeral Fracture Positioning SleeveBiomet, Inc.20041—
+2K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+2K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+2K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+2K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+2K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+2K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+2K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+2K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+2K131633Arthrex Univers ApexArthrex, Inc.20134—
+2K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+2K120794Ascend Shoulder SystemTornier, Inc.201298—
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+2K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+2K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+3K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+3K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+3K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+3K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K213856Identity Shoulder SystemZimmer, Inc.20224—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+3K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+3K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+3K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+3K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K121493Ascend Shoulder SystemTornier, Inc.201297—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+4K250848Identity Shoulder SystemZimmer, Inc.20250—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+5K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+5K163669Humeris ShoulderFx Solutions201720—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+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—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—