510(k) Report

Devices descending from K022239

35 later devices reach Surgetics Entact Endonasal Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+2K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+2K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+3K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+3K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+4K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+4K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+4K210153NextAR RSA PlatformMedacta International S.A.202151
+4K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+4K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+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—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+5K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+5K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+5K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+5K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+5K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+6K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+6K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K231172ApolloKneeCorin U.S.A. Limited20230—
+6K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+7K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+7K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+7K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+8K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+8K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+9K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+9K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+9K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—