510(k) Report

Devices descending from K172219

37 later devices reach Mako Total Knee Application through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+1K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+2K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+2K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+2K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+2K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+2K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+2K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+2K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+2K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+2K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+2K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+3K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+3K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+3K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+3K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+3K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+3K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+3K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+4K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+4K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+5K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+5K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+5K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+5K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+6K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+7K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+8K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+9K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+10K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+11K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+12K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601