510(k) Report

Devices descending from K911686

436 later devices reach Global Total Shoulder, Uncement Humeral Hemi-Shoul through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+5K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+5K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+5K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+5K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+5K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+5K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+5K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+5K150730Zimmer PSI Shoulder SystemZimmer201511—
+5K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141—
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K141006RSP Humeral Socket InsertDjo Global2014212
+5K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+5K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+5K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+5K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+5K121493Ascend Shoulder SystemTornier, Inc.201297—
+5K113413Ascend Shoulder SystemTornier, Inc.2012105—
+5K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+5K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+5K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+5K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+5K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+6K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+6K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K250848Identity Shoulder SystemZimmer, Inc.20250—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K243509Archer PSI System3D-Side20250—
+6K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+6K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+6K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+6K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+6K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+6K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+6K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+6K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+6K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+6K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+6K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+6K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+6K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+6K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+6K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+6K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+6K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+7K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+7K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+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—
+7K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+7K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+7K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+7K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+7K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—