510(k) Report

Devices descending from K043536

342 later devices reach Navitrack System - S&N Image Free Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K250086OTS HipOrtoma AB202511
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242616Lantern® HipOrthalign, Inc.20241—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233899Knee+Pixee Medical20244—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+6K231172ApolloKneeCorin U.S.A. Limited20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+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—
+6K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+6K221028SURGIVISIO DeviceEcential Robotics20227—
+6K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+6K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+6K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+6K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+6K192173ROSA ONE Spine applicationMedtech S.A20190—
+6K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K182417ROSA ONE Brain ApplicationMedtech S.A201913Class I
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+6K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+6K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+6K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+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—
+7K261852OTS HipOrtoma AB20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K242575Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.20250—
+7K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+7K243975Knee+Pixee Medical20253—
+7K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+7K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+7K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+7K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+7K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+7K231886SURGIVISIO DeviceEcential Robotics20236—
+7K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+7K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+7K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+7K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+7K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+7K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—