510(k) Report

Devices descending from K151568

20 later devices reach Arthrex OrthoVis Preoperative Plan through their predicates, nearest generation first.

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