510(k) Report

Devices descending from K961571

147 later devices reach Cocr BI-Angular Humeral Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+7K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+7K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+7K201315PERFORM Humeral System – StemTornier, Inc.2020111
+7K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+7K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+7K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+7K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+7K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+7K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+7K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+7K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+7K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+7K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+7K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+7K152966Aequalis Fx2Tornier S.A.S.201601
+8K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+8K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+8K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+8K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+8K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+8K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+8K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+8K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+8K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+8K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+8K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+8K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+8K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+8K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+9K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+9K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+9K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+9K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+9K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—