510(k) Report

Devices descending from K100742

20 later devices reach Exactech GPS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152764Exactech GPSBlue Ortho2016191
+2K193618ExactechGPS SystemBlue Ortho202021
+2K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+3K213877ExactechGPS® SystemBlue Ortho20221—
+3K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+4K233299ExactechGPS® SystemBlue Ortho20240—
+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—
+5K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+6K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—