510(k) Report

Devices descending from K970604

159 later devices reach Viewpoint - 3.0 Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+10K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+10K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+10K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+10K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+10K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+10K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+10K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+10K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+10K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+10K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+10K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+10K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+10K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+10K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+11K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+11K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+11K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+11K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+11K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+11K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+11K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+11K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+11K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+11K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+11K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+11K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+11K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+11K191223NAVIOBlue Belt Technologies, Inc.201915—
+12K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+12K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+12K252847NextAR Hip PlatformMedacta International S.A.20260—
+12K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+12K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+12K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+12K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+12K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+13K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+13K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+13K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+13K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+14K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+14K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+15K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+15K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+15K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+16K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+16K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+16K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+16K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+17K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+17K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+17K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+18K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+18K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+18K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+18K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+19K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+20K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601