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
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+5K192967Medacta Shoulder SystemMedacta International S.A.20200—
+5K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+5K193099Anatomical Shoulder SystemZimmer GmbH20201—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+5K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+5K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+5K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+5K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+5K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+5K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+5K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+5K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+5K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+5K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+5K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+5K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+5K150730Zimmer PSI Shoulder SystemZimmer201511—
+5K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+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—
+5K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+5K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+5K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+6K260556Veritas Shoulder SystemRestor3D20260—
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+6K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K243509Archer PSI System3D-Side20250—
+6K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+6K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+6K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+6K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+6K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+6K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+6K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+6K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+6K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+6K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+6K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+6K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+6K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+6K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+6K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+6K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+6K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+6K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+7K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+7K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—