510(k) Report

Devices descending from K002053

427 later devices reach Navitrak System-Optical Option, Model 900.004 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243975Knee+Pixee Medical20253—
+8K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+8K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+8K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K242616Lantern® HipOrthalign, Inc.20241—
+8K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233299ExactechGPS® SystemBlue Ortho20240—
+8K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+8K233017TM Plating SystemTyber Medical, LLC20231—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+8K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+8K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+8K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+8K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+8K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+8K221028SURGIVISIO DeviceEcential Robotics20227—
+8K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+8K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+8K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+8K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+8K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+8K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+8K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K202749ADAPT for Gamma3Stryker GmbH20200—
+8K202307Activ FuseNewclip Technics20200—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+8K192173ROSA ONE Spine applicationMedtech S.A20190—
+8K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+8K182417ROSA ONE Brain ApplicationMedtech S.A201913Class I
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+8K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+8K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+8K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+8K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+8K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+8K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+8K163221Mazor XMazor Robotics, Ltd.201719—
+8K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+8K160537NavioBlue Belt Technologies, Inc.201618—
+8K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+8K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K253805Knee+Pixee Medical S.A.S.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K242575Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.20250—
+9K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+9K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+9K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+9K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+9K231886SURGIVISIO DeviceEcential Robotics20236—
+9K230567OptiVu™ ROSA® MxROrthosoft 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—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+9K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—