510(k) Report

Devices descending from K152764

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193618ExactechGPS SystemBlue Ortho202021
+1K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+2K213877ExactechGPS® SystemBlue Ortho20221—
+2K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+3K233299ExactechGPS® SystemBlue Ortho20240—
+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—
+4K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+4K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+4K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+4K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+5K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+5K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+5K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—