510(k) Report

Devices descending from K981487

335 later devices reach Depuy Global Shoulder Glenoid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K150730Zimmer PSI Shoulder SystemZimmer201511—
+3K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+3K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+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—
+3K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+3K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K120794Ascend Shoulder SystemTornier, Inc.201298—
+3K113413Ascend Shoulder SystemTornier, Inc.2012105—
+3K112983Spacer-STecres S.P.A.20117—
+3K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+3K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+3K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.200621
+3K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+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—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+4K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+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
+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—
+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—
+4K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+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—
+4K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+4K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+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—
+4K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+4K193175Lateralized GlenosphereMedacta Inernational SA20201—
+4K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+4K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+4K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+4K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+4K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+4K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+4K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+4K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+4K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+4K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+4K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K121493Ascend Shoulder SystemTornier, Inc.201297—
+4K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412