510(k) Report

Devices descending from K012448

251 later devices reach Vectorvision Trauma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K192592Axis Plating SystemExtremity Medical, LLC20190—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+8K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+8K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+9K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+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—
+9K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+9K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+10K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+10K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+10K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+10K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+10K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+10K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+10K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+10K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+11K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+11K242223SuperSonic HepaVuSupersonic Imagine20240—
+11K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+11K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+11K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+12K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+12K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+12K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+12K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+13K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+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—