510(k) Report

Devices descending from K021478

338 later devices reach Delta Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241043Augment Off-Axis Instrument SystemFix Surgical202415
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+4K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+4K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+4K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+4K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+4K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+4K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+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
+4K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+4K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+4K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+4K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+4K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+4K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+4K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+4K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+4K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+4K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+4K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+4K150730Zimmer PSI Shoulder SystemZimmer201511—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+5K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+5K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+5K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+5K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+5K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+5K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+5K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+5K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+5K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+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—
+5K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+5K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+5K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+5K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+5K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+6K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+6K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K243509Archer PSI System3D-Side20250—