510(k) Report

Devices descending from K021306

387 later devices reach Vectorvision CT-Free Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+10K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+10K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+10K200935Mazor XMazor Robotics, Ltd.202015—
+10K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+10K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+10K191223NAVIOBlue Belt Technologies, Inc.201915—
+10K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+10K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+10K172886Breakaway Screw SystemParagon 2820174—
+10K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+10K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+10K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+11K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+11K242223SuperSonic HepaVuSupersonic Imagine20240—
+11K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+11K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+11K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+11K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+11K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+11K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+11K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+11K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+11K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+11K203005Mazor XMazor Robotics, Ltd.2020141
+11K201149CoLink Plating SystemIn2bones USA, LLC20200—
+11K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+11K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+11K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+11K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+11K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+12K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+12K252246Leforte MMF SystemJeil Medical Corporation20260—
+12K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+12K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+12K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+12K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+12K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+12K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+12K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+12K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+12K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+12K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+12K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+12K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+12K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+12K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+12K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+12K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+12K192592Axis Plating SystemExtremity Medical, LLC20190—
+12K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+13K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+13K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+13K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+13K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+13K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+13K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+13K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+13K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+13K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+13K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+13K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+13K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+14K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+14K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+14K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+14K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+14K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+14K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+14K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+14K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+14K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+14K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+14K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+14K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+15K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+15K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+15K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+15K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+16K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+16K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+17K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+18K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+19K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601