510(k) Report

Devices descending from K123122

56 later devices reach Glenoid Intelligent Reusable Instrument System (Glenoid Iris) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241470CORE Shoulder SystemLinkBio Corp.202501
+1K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+1K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+1K131129Cas Psi ShoulderZimmer Cas201339—
+2K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+2K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+2K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+2K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+2K150730Zimmer PSI Shoulder SystemZimmer201511—
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+3K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+3K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+3K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+3K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+4K243509Archer PSI System3D-Side20250—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+4K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+4K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+4K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+4K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+5K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+5K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+5K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+6K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+6K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+6K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—