510(k) Report

Devices descending from K003347

436 later devices reach Orthopilot through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG2006126—
+1K061224Lapdoc IRobodent GmbH20060—
+1K033668Navipro Knee Software ModuleKinamed, Inc.200440—
+1K023424Igi-SystemDenx Advanced Dental Systems200329—
+1K021760Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc.2002363—
+1K021327Orthopilot Hto ModuleAesculap, Inc.20020—
+1K020764NaviproKinamed, Inc.200241—
+1K020298Galileo Cas/Nav TKR SystemPlus Orthopedics20021271
+1K013569Orthopilot 2Aesculap, Inc.2002153—
+2K150222X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2015261
+2K102990Brainlab KneeBrainlab AG201171
+2K083872Imns Medacta Navigation SystemMedacta International S.A.200914—
+2K082267Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1Smith & Nephew, Inc.20081—
+2K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+2K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+2K080547Orthopilot Next Generation, Model FS101-FS106Aesculap Implant System, Inc.200822—
+2K072899Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0Aesculap Implant Systems, Inc.20080—
+2K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+2K060336Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc.2006913
+2K052840Igi-SystemDenx Advanced Dental Systems20050—
+2K031196Surgetics Ortho Kneelogics Navigation SystemPraxim2005149—
+2K050897Navipro Shoulder Software ModuleKinamed, Inc.200539—
+2K050752Aesculap Orthopilot 2 Tha V 2.0Aesculap, Inc.200583—
+2K043536Navitrack System - S&N Image Free KneeOrthosoft, Inc.2005342—
+3K220652Knee 3Brainlab AG20220—
+3K213392INLIANT Surgical Navigation SystemNavigate Surgical Technologies, Inc.20220—
+3K200805Neocis Guidance System (NGS) with Patient SplintsNeocis, Inc.20201—
+3K193559NextAR TKA PlatformMedacta Inernational SA202012—
+3K200662X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC20200—
+3K192579X-Guide Surgical Navigation SystemX-Nav Technologies, LLC20203—
+3K161399Neocis Guidance SystemNeocis, Inc.2016151
+3K161406NavidentClaronav, Inc.20161—
+3K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+3K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+3K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K103829Kneealign SystemOrthalign, Inc.201139—
+3K110054Navitrack System - OS Knee Universal, Cas Same Incision Tibia ReferenceZimmer Cas201192
+3K100314Imns Medacta Navigation System,33.221000USMedacta International S.A.201013—
+3K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+3K090375Orthopilot Next Generation-Uka Software, Model FS210Aesculap Implant System, Inc.200921—
+3K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+3K090313Pigalileo TKR Base V2.3 and Cas V4.1Smith & Nephew, Inc.20090—
+3K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+3K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc.200723
+3K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc.2007792
+3K062146Uni Knee Surgetics Navigation SystemPraxim S.A200699—
+3K060556Brigit Surgical DeviceZimmer, Inc.2006128—
+3K053542Surgetics Ortho Osteologics Navigation SystemPraxim S.A20060—
+3K060282Total Knee Surgetics Navigation SystemPraxim S.A2006147—
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+4K210947NavidentClaronav, Inc.20220—
+4K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+4K211701X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC202221
+4K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+4K211129Neocis Guidance System (NGS) with Intraoral Fiducial ArrayNeocis, Inc.20210—
+4K210153NextAR RSA PlatformMedacta International S.A.202151
+4K202750Knee+Pixee Medical20218—
+4K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+4K203401Neocis Guidance System (NGS) with Patient Splints (EPS)Neocis, Inc.20200—
+4K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc.20207—
+4K202152NextAR TKA PlatformMedacta International S.A.202011—
+4K193307HIP7Brainlab AG20200—
+4K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+4K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+4K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+4K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc.201854
+4K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+4K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+4K153396Aesculap OrthoPilot Next GenerationAesculap Implant Systems, LLC20160—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K141694Aesculap Orthopilot Next GenerationAesculap Implant Systems, LLC201519—
+4K140331Orthalign Plus SystemOrthalign, Inc.201429—
+4K121936NaviopfsBlue Belt Technologies, Inc.2012222
+4K122326Smarttools Knee SystemZimmer201232
+4K100742Exactech GPSBlue Ortho201020—
+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—
+4K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+4K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A20091279
+4K091411Kneealign SystemOrthalign, Inc.200941—
+4K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+4K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+4K072267Total Hip Surgetics Navigation SystemPraxim S.A20070—
+4K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+5K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+5K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+5K250477NextAR (TM) SpineMedacta International S.A.20250—
+5K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K232140OTS HipOrtoma AB202421
+5K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLC202412
+5K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+5K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+5K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+5K223351Naviswiss KneeNaviswiss AG20230—
+5K220104Knee+Pixee Medical20227—
+5K211466Yomi Robotic System with YomiPlan GoNeocis, Inc.20220—
+5K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc.20215—
+5K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—