510(k) Report

Devices descending from K133367

23 later devices reach Orthovis Preoperative Plan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+1K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+1K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+2K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+2K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+2K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+2K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+3K241470CORE Shoulder SystemLinkBio Corp.202501
+3K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+3K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+4K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+4K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+4K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+4K210153NextAR RSA PlatformMedacta International S.A.202151
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+5K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+5K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+5K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—