510(k) Report

Devices descending from K983831

611 later devices reach VECTORVISION2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+8K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+8K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+8K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+8K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+8K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+8K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+8K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+8K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+8K173526SENTIO MMG Gen 2Medos International SARL20182—
+8K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+8K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+8K152574NavioBlue Belt Technologies, Inc.201519—
+8K141601Iassist Knee SystemZimmer Cas20142—
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+9K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+9K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K252376Yomi S Robotic SystemNeocis, Inc.20250—
+9K251835Yomi Robotic SystemNeocis, Inc.20250—
+9K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+9K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+9K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+9K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+9K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+9K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+9K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+9K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+9K231172ApolloKneeCorin U.S.A. Limited20230—
+9K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+9K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+9K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+9K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+9K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+9K192592Axis Plating SystemExtremity Medical, LLC20190—
+9K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+9K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+9K160537NavioBlue Belt Technologies, Inc.201618—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+10K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+10K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+10K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+10K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+10K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+10K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+10K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+10K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+10K170360NAVIOBlue Belt Technologies, Inc.201717—
+11K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+11K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+11K242223SuperSonic HepaVuSupersonic Imagine20240—
+11K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+11K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+11K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+11K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+11K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+11K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+12K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+12K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+12K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+12K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+12K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+12K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+12K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+12K191223NAVIOBlue Belt Technologies, Inc.201915—
+13K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—