510(k) Report

Devices descending from K031337

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+1K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+1K043223Depuy Cas Knee InstrumentationDePuy Orthopaedics, Inc.200511
+2K140596NAVIOBlue Belt Technologies, Inc.201421—
+2K121936NaviopfsBlue Belt Technologies, Inc.2012222
+2K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+2K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+2K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+2K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+2K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp.20060—
+3K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+3K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+3K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+3K143668NavioBlue Belt Technologies, Inc.201520—
+3K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+3K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+4K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+4K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+4K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+4K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+4K152574NavioBlue Belt Technologies, Inc.201519—
+4K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+5K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+5K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+5K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+5K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+5K160537NavioBlue Belt Technologies, Inc.201618—
+6K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+6K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+6K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+6K170360NAVIOBlue Belt Technologies, Inc.201717—
+7K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+7K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+7K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+7K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+7K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+7K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+7K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+7K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+7K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+7K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+8K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+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—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—
+9K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+9K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+9K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+9K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+9K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+10K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+10K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+10K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+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—
+15K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+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