510(k) Report

Devices descending from K030259

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+4K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+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—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+5K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+5K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+5K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+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—
+5K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+5K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+5K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+5K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+5K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+5K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+5K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+5K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+5K152966Aequalis Fx2Tornier S.A.S.201601
+5K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K141006RSP Humeral Socket InsertDjo Global2014212
+5K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+5K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K120794Ascend Shoulder SystemTornier, Inc.201298—
+6K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K243509Archer PSI System3D-Side20250—
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+6K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+6K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+6K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+6K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+6K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+6K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+6K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+6K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+6K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+6K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+6K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+6K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+6K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K121493Ascend Shoulder SystemTornier, Inc.201297—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+7K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—