510(k) Report

Devices descending from K060692

138 later devices reach Comprehensive Primary Shoulder Stems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+5K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+5K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+5K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+5K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+5K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+5K152966Aequalis Fx2Tornier S.A.S.201601
+6K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+7K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+7K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+7K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+7K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—