510(k) Report

Devices descending from K023975

172 later devices reach Voyager Linux through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050973Modification to: Voyager LinuxMako Surgical Corp.200597—
+1K031454Acumen Surgical Navigation SystemBiomet, Inc.2004146—
+1K031732Ebi Acumen Surgical Navigation SystemEbi, L.P.20030—
+1K031337Acumen Surgical Navigation SystemBiomet, Inc.200381—
+1K030764Z-BOXZ-Kat, Inc.20032—
+2K111863Signature Planner,Signature GuidesMaterialise NV201271—
+2K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+2K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+2K052851Voyager Linux with Tactile Guidance System (TGS)Mako Surgical Corp.200596—
+2K051724Acumen Image Guided Surgical SystemEbi, L.P.20050—
+2K043223Depuy Cas Knee InstrumentationDePuy Orthopaedics, Inc.200511
+3K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+3K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+3K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+3K140596NAVIOBlue Belt Technologies, Inc.201421—
+3K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+3K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+3K121936NaviopfsBlue Belt Technologies, Inc.2012222
+3K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+3K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+3K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+3K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+3K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc.200816—
+3K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp.20060—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K202484Cordera Hip SystemConformis, Inc.202022
+4K192198Conformis Hip SystemConformis, Inc.2019121
+4K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+4K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+4K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+4K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K143668NavioBlue Belt Technologies, Inc.201520—
+4K140585CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation201410—
+4K140038Digimatch Orthodoc Robodoc Encore Surgical SystemCurexo Technology Corporation20140—
+4K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+4K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+4K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.20113—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+5K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+5K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+5K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+5K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+5K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+5K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+5K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+5K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+5K152574NavioBlue Belt Technologies, Inc.201519—
+5K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+5K123548The Artas SystemRestoration Robotics, Inc.201314
+5K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.20130—
+6K243509Archer PSI System3D-Side20250—
+6K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+6K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K173358ARTAS SystemRestoration Robotics, Inc.20180—
+6K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+6K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+6K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+6K160537NavioBlue Belt Technologies, Inc.201618—
+6K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+7K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+7K241470CORE Shoulder SystemLinkBio Corp.202501
+7K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+7K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+7K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+7K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+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—
+7K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+8K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—