510(k) Report

Devices descending from K182964

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+1K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+1K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+1K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+1K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+1K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+1K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+1K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+2K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+2K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+2K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+2K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+2K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+2K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+3K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+3K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+3K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+4K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+4K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+4K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+4K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+5K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+5K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+6K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+7K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+8K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+9K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+10K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+11K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601