510(k) Report

Devices descending from K031770

134 later devices reach CI TKR/Ukr through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+11K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+11K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+11K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+12K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+12K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+12K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+12K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+12K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+12K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+12K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+12K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+13K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+13K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+13K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+13K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+14K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+14K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+14K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+14K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+15K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+15K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+15K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+15K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+16K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+16K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+16K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+17K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+17K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+17K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+17K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+17K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+18K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+19K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601