510(k) Report

Devices descending from K992065

405 later devices reach Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+5K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+5K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+5K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+5K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+5K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+5K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+5K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+5K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+5K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+5K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+5K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+5K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+5K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+5K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+5K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+5K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+5K120794Ascend Shoulder SystemTornier, Inc.201298—
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+6K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+6K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+6K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+6K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+6K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+6K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+6K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—
+6K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+6K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+6K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+6K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+6K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+6K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+6K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+6K121493Ascend Shoulder SystemTornier, Inc.201297—
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+7K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+7K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+7K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+7K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—