510(k) Report

Devices descending from K914695

451 later devices reach Global Total Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+7K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+7K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+7K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+7K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+7K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+7K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+8K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+8K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+8K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+8K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+8K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+8K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+8K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+8K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+8K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+8K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+8K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+8K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+8K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+8K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+8K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+9K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+9K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+9K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+9K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+9K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+9K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+9K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+9K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+9K210153NextAR RSA PlatformMedacta International S.A.202151
+9K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+9K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+10K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+10K252847NextAR Hip PlatformMedacta International S.A.20260—
+10K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+10K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+10K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+11K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—