510(k) Report

Devices descending from K170581

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+2K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+2K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+3K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+3K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+3K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+3K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+3K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+3K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+3K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+3K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+3K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+3K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+4K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+4K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+4K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+4K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+4K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+4K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+4K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+5K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+5K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+8K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+9K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+10K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+11K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+12K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+13K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601