510(k) Report

Devices descending from K041899

133 later devices reach Vectorvision Uni-Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073615Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedBrainlab AG200852—
+1K080678Uni-Knee 2.0Brainlab AG20081—
+1K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+1K052966CI Knee, CI MI TKRBrainlab AG200654—
+2K220652Knee 3Brainlab AG20220—
+2K102251Dash KneeBrainlab AG201110—
+2K102990Brainlab KneeBrainlab AG201171
+2K093118Brainlab Knee ArthroscopyBrainlab AG20100—
+2K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+2K091411Kneealign SystemOrthalign, Inc.200941—
+2K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+2K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+3K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+3K140596NAVIOBlue Belt Technologies, Inc.201421—
+3K121936NaviopfsBlue Belt Technologies, Inc.2012222
+3K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+3K103829Kneealign SystemOrthalign, Inc.201139—
+3K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+3K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+4K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+4K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+4K193307HIP7Brainlab AG20200—
+4K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+4K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+4K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+4K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+4K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+4K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+4K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+4K143668NavioBlue Belt Technologies, Inc.201520—
+4K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+4K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+4K122326Smarttools Knee SystemZimmer201232
+4K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+5K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+5K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+5K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+5K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+5K232140OTS HipOrtoma AB202421
+5K223351Naviswiss KneeNaviswiss AG20230—
+5K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+5K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+5K192653PerseusOrthokey Italia S.R.L.20200—
+5K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+5K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+5K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+5K152574NavioBlue Belt Technologies, Inc.201519—
+5K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+5K141601Iassist Knee SystemZimmer Cas20142—
+5K140331Orthalign Plus SystemOrthalign, Inc.201429—
+6K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+6K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+6K250086OTS HipOrtoma AB202511
+6K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+6K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+6K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+6K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+6K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+6K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+6K160537NavioBlue Belt Technologies, Inc.201618—
+6K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+6K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+7K261852OTS HipOrtoma AB20260—
+7K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+7K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+7K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+7K170360NAVIOBlue Belt Technologies, Inc.201717—
+7K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+7K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+8K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+8K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+8K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+8K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+8K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+8K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+8K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+8K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+8K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+8K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+8K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+8K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+8K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+9K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+9K242616Lantern® HipOrthalign, Inc.20241—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+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—
+9K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+9K191223NAVIOBlue Belt Technologies, Inc.201915—
+9K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+10K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+10K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+10K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—