510(k) Report

Devices descending from K021306

387 later devices reach Vectorvision CT-Free 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—
+1K052966CI Knee, CI MI TKRBrainlab AG200654—
+1K031196Surgetics Ortho Kneelogics Navigation SystemPraxim2005149—
+1K042513Vectorvision OsteotomyBrainlab AG200513—
+1K042512Vectorvision AclBrainlab AG200557—
+1K041899Vectorvision Uni-KneeBrainlab AG2004133—
+1K040368Vectorvision Hip 3.0Brainlab AG2004180—
+1K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+1K031770CI TKR/UkrBrainlab AG2003134—
+2K220652Knee 3Brainlab AG20220—
+2K111843Acufex Director Application Anatomic Guide SystemSmith & Nephew Inc., Endoscopy Div.20110—
+2K102251Dash KneeBrainlab AG201110—
+2K102990Brainlab KneeBrainlab AG201171
+2K093206Orthomap 3D 1.1 ModuleStryker Corp.20100—
+2K093118Brainlab Knee ArthroscopyBrainlab AG20100—
+2K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+2K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+2K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+2K091411Kneealign SystemOrthalign, Inc.200941—
+2K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+2K083483Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG200970—
+2K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+2K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+2K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+2K072716Vector Vision HipBrainlab AG200784—
+2K072573Vectorvision Hip and Hip SRBrainlab AG20070—
+2K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+2K063028Vectorvision Hip SRBrainlab AG200611—
+2K062146Uni Knee Surgetics Navigation SystemPraxim S.A200699—
+2K060727Vectorvision HipBrainlab AG200671—
+2K053542Surgetics Ortho Osteologics Navigation SystemPraxim S.A20060—
+2K060282Total Knee Surgetics Navigation SystemPraxim S.A2006147—
+2K060121Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip ApplicationsBiomet Manufacturing Corp20060—
+2K060468Vectorvision HipBrainlab AG2006154—
+2K052213Navigation SW Hip 3.1 on CIBrainlab AG2005170—
+2K052178Depuy Cas Hip InstrumentationDePuy Orthopaedics, Inc.20052—
+2K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+3K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+3K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+3K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+3K110021Dash HipBrainlab AG201147—
+3K110204Brainlab TraumaBrainlab AG201127—
+3K103829Kneealign SystemOrthalign, Inc.201139—
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K100742Exactech GPSBlue Ortho201020—
+3K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+3K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+3K072271Stryker Navigation System Infinitus Hip Resurfacing ModuleStryker Corp.20070—
+3K072267Total Hip Surgetics Navigation SystemPraxim S.A20070—
+3K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc.200723
+3K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+3K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc.2007792
+3K071135Depuy CI Hip InstrumentationDePuy Orthopaedics, Inc.20070—
+3K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+4K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+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—
+4K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+4K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+4K161999AixplorerSupersonic Imagine201620—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K152764Exactech GPSBlue Ortho2016191
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+4K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+4K140596NAVIOBlue Belt Technologies, Inc.201421—
+4K140331Orthalign Plus SystemOrthalign, Inc.201429—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+4K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+4K121936NaviopfsBlue Belt Technologies, Inc.2012222
+4K122326Smarttools Knee SystemZimmer201232
+4K121384MylabsognoEsaote, S.p.A.201211
+4K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K110688MylabgoldEsaote2011251
+4K110911Renaissance SystemMazor Robotics, Ltd.201124—
+4K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+4K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton…Orthosoft, Inc.20101—
+4K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+4K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+4K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+5K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+5K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+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—