510(k) Report

Devices descending from K013025

151 later devices reach Modification to Flourolab Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+8K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+8K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+8K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+8K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+9K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+9K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+9K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+9K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+9K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+9K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+9K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+9K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+9K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+9K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+9K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+9K191223NAVIOBlue Belt Technologies, Inc.201915—
+10K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+10K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+10K252847NextAR Hip PlatformMedacta International S.A.20260—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+10K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+10K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+10K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+11K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+11K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+11K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+12K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+12K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+13K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+13K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+13K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+14K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+14K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+14K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+14K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+15K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+15K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+15K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+16K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+16K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+16K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+16K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+17K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+18K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601