510(k) Report

Devices descending from K221928

8 later devices reach ROSA® Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+1K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+2K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+2K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+3K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+3K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+3K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+4K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—