510(k) Report

Devices descending from K000310

190 later devices reach Voyager 6.0 Software Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023975Voyager LinuxZ-Kat, Inc.2002172—
+1K022239Surgetics Entact Endonasal Navigation SystemPraxim200235—
+1K013025Modification to Flourolab PlusZ-Kat, Inc.2001151—
+2K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+2K050973Modification to: Voyager LinuxMako Surgical Corp.200597—
+2K031454Acumen Surgical Navigation SystemBiomet, Inc.2004146—
+2K031732Ebi Acumen Surgical Navigation SystemEbi, L.P.20030—
+2K031337Acumen Surgical Navigation SystemBiomet, Inc.200381—
+2K030764Z-BOXZ-Kat, Inc.20032—
+3K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+3K111863Signature Planner,Signature GuidesMaterialise NV201271—
+3K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+3K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+3K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+3K052851Voyager Linux with Tactile Guidance System (TGS)Mako Surgical Corp.200596—
+3K051724Acumen Image Guided Surgical SystemEbi, L.P.20050—
+3K043223Depuy Cas Knee InstrumentationDePuy Orthopaedics, Inc.200511
+4K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+4K140596NAVIOBlue Belt Technologies, Inc.201421—
+4K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+4K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+4K121936NaviopfsBlue Belt Technologies, Inc.2012222
+4K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+4K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+4K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+4K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+4K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+4K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc.200816—
+4K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp.20060—
+5K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+5K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K202484Cordera Hip SystemConformis, Inc.202022
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+5K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+5K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+5K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+5K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+5K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+5K143668NavioBlue Belt Technologies, Inc.201520—
+5K140585CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation201410—
+5K140038Digimatch Orthodoc Robodoc Encore Surgical SystemCurexo Technology Corporation20140—
+5K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+5K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+5K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.20113—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+6K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+6K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+6K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+6K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+6K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+6K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+6K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+6K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+6K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+6K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+6K152574NavioBlue Belt Technologies, Inc.201519—
+6K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+6K123548The Artas SystemRestoration Robotics, Inc.201314
+6K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.20130—
+7K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K243509Archer PSI System3D-Side20250—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—