510(k) Report

Devices descending from K031770

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052966CI Knee, CI MI TKRBrainlab AG200654—
+1K041899Vectorvision Uni-KneeBrainlab AG2004133—
+2K073615Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedBrainlab AG200852—
+2K080678Uni-Knee 2.0Brainlab AG20081—
+2K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+3K220652Knee 3Brainlab AG20220—
+3K102251Dash KneeBrainlab AG201110—
+3K102990Brainlab KneeBrainlab AG201171
+3K093118Brainlab Knee ArthroscopyBrainlab AG20100—
+3K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+3K091411Kneealign SystemOrthalign, Inc.200941—
+3K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+3K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+4K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+4K140596NAVIOBlue Belt Technologies, Inc.201421—
+4K121936NaviopfsBlue Belt Technologies, Inc.2012222
+4K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+4K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+4K103829Kneealign SystemOrthalign, Inc.201139—
+4K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+4K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+5K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+5K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+5K193307HIP7Brainlab AG20200—
+5K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+5K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+5K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+5K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+5K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+5K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+5K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+5K143668NavioBlue Belt Technologies, Inc.201520—
+5K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+5K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+5K122326Smarttools Knee SystemZimmer201232
+5K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+6K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+6K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+6K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+6K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+6K232140OTS HipOrtoma AB202421
+6K223351Naviswiss KneeNaviswiss AG20230—
+6K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+6K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+6K192653PerseusOrthokey Italia S.R.L.20200—
+6K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+6K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+6K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+6K152574NavioBlue Belt Technologies, Inc.201519—
+6K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+6K141601Iassist Knee SystemZimmer Cas20142—
+6K140331Orthalign Plus SystemOrthalign, Inc.201429—
+7K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+7K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+7K250086OTS HipOrtoma AB202511
+7K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+7K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+7K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+7K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+7K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+7K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+7K160537NavioBlue Belt Technologies, Inc.201618—
+7K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+7K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+8K261852OTS HipOrtoma AB20260—
+8K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+8K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+8K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+8K170360NAVIOBlue Belt Technologies, Inc.201717—
+8K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+8K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+9K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+9K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+9K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+9K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+9K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+9K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+9K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+9K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+9K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+9K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+9K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+9K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+9K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+10K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+10K242616Lantern® HipOrthalign, Inc.20241—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+10K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+10K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+10K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+10K191223NAVIOBlue Belt Technologies, Inc.201915—
+10K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+11K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+11K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—