510(k) Report

Devices descending from K230243

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

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