510(k) Report

Devices descending from K905070

166 later devices reach Vistar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+12K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+12K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+12K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+12K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+12K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+12K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+12K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+12K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+12K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+12K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+12K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+12K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+12K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+12K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+12K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+12K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+12K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+12K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+12K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+12K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+12K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+13K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+13K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+13K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+13K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+13K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+13K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+13K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+13K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+13K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+13K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+13K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+13K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+13K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+13K191223NAVIOBlue Belt Technologies, Inc.201915—
+14K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+14K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+14K252847NextAR Hip PlatformMedacta International S.A.20260—
+14K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+14K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+14K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+14K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+14K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+15K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+15K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+15K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+15K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+16K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+16K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+17K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+17K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+17K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+18K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+18K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+18K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+18K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+19K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+19K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+19K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+20K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+20K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+20K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+20K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+21K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+22K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601