510(k) Report

Devices descending from K030259

331 later devices reach Amatomical Shoulder with Removable Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+1K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+1K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+1K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+1K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A.201138—
+1K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A.2010372
+1K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+1K060874Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc.2006200—
+1K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+2K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+2K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+2K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+2K193099Anatomical Shoulder SystemZimmer GmbH20201—
+2K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+2K161476SMR Shoulder SystemLima Corporate S.P.A.20161—
+2K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+2K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+2K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+2K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+2K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+2K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+2K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+2K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+2K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+2K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+2K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+2K103251Duocentric ReversedAston Medical20117—
+2K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+2K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+2K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.201134—
+2K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+2K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+2K071948Aequalis Reversed AdapterTornier2007178—
+2K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+2K063652Global AP Porous Coated Humeral StemDePuy Orthopaedics, Inc.200718—
+2K063081Aequalis Shoulder SystemTornier2006162—
+3K260556Veritas Shoulder SystemRestor3D20260—
+3K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K241470CORE Shoulder SystemLinkBio Corp.202501
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+3K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+3K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+3K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+3K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+3K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+3K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+3K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+3K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+3K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+3K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+3K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+3K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+3K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+3K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+3K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+3K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+3K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K163669Humeris ShoulderFx Solutions201720—
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+3K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+3K140071Humelock II Cemented Shoulder SystemFx Solutions201431—
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—