510(k) Report

Devices descending from K092122

75 later devices reach Global Shoulder Steptech Anchor Peg Glenoid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+1K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+2K241470CORE Shoulder SystemLinkBio Corp.202501
+2K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+2K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+2K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+2K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+2K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+2K131129Cas Psi ShoulderZimmer Cas201339—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+3K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+3K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+3K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+3K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+3K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+3K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+3K150730Zimmer PSI Shoulder SystemZimmer201511—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+4K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+4K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K243509Archer PSI System3D-Side20250—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+5K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+5K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+5K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+5K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+6K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K210153NextAR RSA PlatformMedacta International S.A.202151
+6K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+6K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+7K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+7K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+7K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+7K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+7K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+7K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+7K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+8K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+9K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—