510(k) Report

Devices descending from K800494

415 later devices reach New Jersey Hemiarthroplasty Sholder Pros through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K213856Identity Shoulder SystemZimmer, Inc.20224—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+6K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+6K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+6K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+6K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+6K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+6K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+6K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+6K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+6K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+6K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+6K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+6K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+6K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+6K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+6K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+6K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+6K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+6K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+6K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+6K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+6K150730Zimmer PSI Shoulder SystemZimmer201511—
+6K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+6K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+6K121493Ascend Shoulder SystemTornier, Inc.201297—
+6K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+6K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+6K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+7K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+7K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+7K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+7K250848Identity Shoulder SystemZimmer, Inc.20250—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+7K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+7K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+7K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+7K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+7K202338SpaceFlex ShoulderG21, S.R.L.20211—
+7K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+7K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+7K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+7K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+7K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+7K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+7K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+7K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+7K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+7K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+7K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+7K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+7K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+7K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+7K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+8K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K243509Archer PSI System3D-Side20250—
+8K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+8K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+8K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+8K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+8K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+8K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+8K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+8K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+9K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+9K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+9K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+9K210153NextAR RSA PlatformMedacta International S.A.202151
+9K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+9K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+9K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932