510(k) Report

Devices descending from K992065

405 later devices reach Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—