510(k) Report

Devices descending from K062250

250 later devices reach Delta Xtend Reverse Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K150730Zimmer PSI Shoulder SystemZimmer201511—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+3K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K141006RSP Humeral Socket InsertDjo Global2014212
+3K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+3K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+3K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K201315PERFORM Humeral System – StemTornier, Inc.2020111
+4K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+4K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+4K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+4K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+4K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+4K163669Humeris ShoulderFx Solutions201720—
+4K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+4K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+4K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+4K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+4K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K243509Archer PSI System3D-Side20250—
+5K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+5K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+5K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+5K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+5K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+5K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+5K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381