510(k) Report

Devices descending from K994392

290 later devices reach Aequalis Shoulder Fracture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K141006RSP Humeral Socket InsertDjo Global2014212
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+3K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K112983Spacer-STecres S.P.A.20117—
+3K103251Duocentric ReversedAston Medical20117—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+3K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K071948Aequalis Reversed AdapterTornier2007178—
+3K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+4K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K243509Archer PSI System3D-Side20250—
+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—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+4K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+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—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+4K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+4K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+4K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+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—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+4K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+4K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+4K113413Ascend Shoulder SystemTornier, Inc.2012105—
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—