510(k) Report

Devices descending from K012212

246 later devices reach Modification to Aequalis Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+4K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+4K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K201315PERFORM Humeral System – StemTornier, Inc.2020111
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+4K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+4K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+4K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+4K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+5K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+5K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—