510(k) Report

Devices descending from K870262

236 later devices reach Fenlin II Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+2K102670Total Shoulder SystemShoulder Innovations, LLC201118—
+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—
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K110905Total Shoulder SystemShoulder Innovations, LLC20110—
+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—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+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—
+4K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+4K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+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
+4K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+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—
+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—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+5K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—
+5K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K192967Medacta Shoulder SystemMedacta International S.A.20200—
+5K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+5K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+5K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+5K170452Medacta Shoulder SystemMedacta International S.A.201712—
+5K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+5K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+5K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+5K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+5K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+5K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+5K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+5K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+5K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+5K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+5K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+5K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+5K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+5K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+5K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+5K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—