510(k) Report

Devices descending from K974044

440 later devices reach Global Total Shoulder Eccentric Humeral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+3K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+3K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+3K131633Arthrex Univers ApexArthrex, Inc.20134—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+3K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+3K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+3K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120—
+3K120794Ascend Shoulder SystemTornier, Inc.201298—
+3K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+3K113413Ascend Shoulder SystemTornier, Inc.2012105—
+3K112983Spacer-STecres S.P.A.20117—
+3K111902Aequalis Shoulder SystemTornier201149—
+3K103251Duocentric ReversedAston Medical20117—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+3K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+3K103007Affiniti Total and Hemi-Shoulder SystemTornier, Inc.201071—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+3K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+3K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+3K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+3K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+3K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+3K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+3K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+3K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC20083—
+3K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+3K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+3K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+3K063652Global AP Porous Coated Humeral StemDePuy Orthopaedics, Inc.200718—
+3K063081Aequalis Shoulder SystemTornier2006162—
+3K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.200621
+3K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006295—
+3K061439Aequalis Reversed ProsthesisTornier2006199—
+3K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+3K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+3K050315Delta Humeral CupsDePuy Orthopaedics, Inc.2005196—
+3K050316Aequalis Reversed Shoulder ProsthesisTornier2005248—
+3K041873Aequalis Reversed Shoulder ProsthesisTornier2004277—
+3K030941Aequalis Reversed Shoulder ProsthesisTornier2004280—
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+4K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241470CORE Shoulder SystemLinkBio Corp.202501
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+4K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K213856Identity Shoulder SystemZimmer, Inc.20224—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—