510(k) Report

Devices descending from K063081

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+6K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+6K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+6K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+6K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+6K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+6K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+6K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+6K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+6K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+6K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+6K152966Aequalis Fx2Tornier S.A.S.201601
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+7K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K240876Identity Shoulder SystemZimmer, Inc.20241—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+7K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+8K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+8K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+8K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+9K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+10K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—