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
+7K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+7K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+7K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+7K202307Activ FuseNewclip Technics20200—
+7K200511ROSA ONE Brain applicationMedtech S.A20205Class I
+7K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+7K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+7K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+7K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+7K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+7K160537NavioBlue Belt Technologies, Inc.201618—
+7K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+7K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+7K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+8K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253805Knee+Pixee Medical S.A.S.20260—
+8K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+8K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+8K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+8K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+8K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+8K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K220072Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd.20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+8K214065ROSA ONE Brain applicationMedtech S.A.S20221—
+8K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+8K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+8K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+8K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+8K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+8K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+8K172886Breakaway Screw SystemParagon 2820174—
+8K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+8K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+8K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+8K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+8K170360NAVIOBlue Belt Technologies, Inc.201717—
+8K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+8K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+9K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+9K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+9K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+9K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+9K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+9K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+9K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+9K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+9K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+9K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+9K231103ROSA ONE Brain ApplicationMedtech S.A.S20230—
+9K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+9K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+9K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+9K201149CoLink Plating SystemIn2bones USA, LLC20200—
+9K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+9K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+9K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+9K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+9K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+10K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K254158SPINEART Navigation Instrument SystemSpineart SA20261—