510(k) Report

Devices descending from K060282

147 later devices reach Total Knee Surgetics Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+9K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+9K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+9K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+9K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+9K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+9K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+9K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+9K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+9K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+9K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+9K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+9K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+10K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+10K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+10K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+10K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+10K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+10K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+10K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+10K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+10K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+10K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+10K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+10K191223NAVIOBlue Belt Technologies, Inc.201915—
+11K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+11K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+11K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+11K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+11K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+11K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+12K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+12K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+12K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+12K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+13K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+13K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+14K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+14K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+15K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+16K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+17K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+18K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+19K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601