510(k) Report

Devices descending from K081867

76 later devices reach Mako Surgical Tactile Guidance System Version 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140596NAVIOBlue Belt Technologies, Inc.201421—
+1K121936NaviopfsBlue Belt Technologies, Inc.2012222
+1K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+1K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+1K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+2K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+2K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+2K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+2K143668NavioBlue Belt Technologies, Inc.201520—
+2K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+2K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+3K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+3K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+3K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+3K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+3K152574NavioBlue Belt Technologies, Inc.201519—
+3K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+4K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+4K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+4K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+4K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+4K160537NavioBlue Belt Technologies, Inc.201618—
+5K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+5K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+5K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+5K170360NAVIOBlue Belt Technologies, Inc.201717—
+6K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+6K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+6K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+6K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+6K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+6K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+6K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+6K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+6K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+6K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+7K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+7K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+7K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+7K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+7K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+7K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+7K191223NAVIOBlue Belt Technologies, Inc.201915—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+8K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+8K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+9K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+10K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+10K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+11K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+11K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+11K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+12K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+12K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+12K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+12K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+13K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+13K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+13K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+14K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+14K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+14K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+14K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+14K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+15K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+16K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601