510(k) Report

Devices descending from K021760

363 later devices reach Navitrack System-Optical TKR CT-Less, Model 900.120 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+6K250086OTS HipOrtoma AB202511
+6K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+6K233899Knee+Pixee Medical20244—
+6K231172ApolloKneeCorin U.S.A. Limited20230—
+6K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+6K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+6K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+6K213877ExactechGPS® SystemBlue Ortho20221—
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+6K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+6K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+6K182848ROSA ONE Spine applicationMedtech S.A201910—
+6K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+6K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+6K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+6K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+6K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+6K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+6K152574NavioBlue Belt Technologies, Inc.201519—
+6K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+6K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+6K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+6K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+6K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+6K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+6K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+6K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+6K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+6K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261852OTS HipOrtoma AB20260—
+7K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+7K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243975Knee+Pixee Medical20253—
+7K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+7K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242616Lantern® HipOrthalign, Inc.20241—
+7K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233299ExactechGPS® SystemBlue Ortho20240—
+7K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+7K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+7K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+7K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+7K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+7K221028SURGIVISIO DeviceEcential Robotics20227—
+7K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+7K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+7K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+7K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+7K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K202307Activ FuseNewclip Technics20200—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+7K192173ROSA ONE Spine applicationMedtech S.A20190—
+7K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—