510(k) Report

Devices descending from K031454

146 later devices reach Acumen Surgical Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+7K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+8K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+8K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+8K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+8K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+8K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+8K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+8K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+8K191223NAVIOBlue Belt Technologies, Inc.201915—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+9K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+9K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+9K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+10K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+10K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+10K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+11K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+11K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+12K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+12K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+12K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+13K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+13K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+13K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+13K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+14K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+14K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+14K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+15K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+15K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+15K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+15K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+16K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+17K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601