510(k) Report

Devices descending from K962315

335 later devices reach Select Shoulder Cocr Humeral Stem Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+4K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+4K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+4K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+4K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+4K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+4K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+4K103251Duocentric ReversedAston Medical20117—
+4K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+4K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+4K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+4K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+4K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+4K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+4K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+4K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+4K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+4K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+5K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+5K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+5K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K192967Medacta Shoulder SystemMedacta International S.A.20200—
+5K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+5K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+5K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+5K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+5K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+5K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+5K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+5K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+5K171841Arthrex Shoulder SystemArthrex, Inc.20181—