510(k) Report

Devices descending from K021306

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+7K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+7K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+7K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+7K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+7K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+7K163221Mazor XMazor Robotics, Ltd.201719—
+7K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+7K160537NavioBlue Belt Technologies, Inc.201618—
+7K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+7K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+7K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+7K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+7K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+8K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+8K242616Lantern® HipOrthalign, Inc.20241—
+8K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+8K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+8K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+8K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+8K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+8K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+8K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+8K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+8K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+8K180307Mazor XMazor Robotics, Ltd.201817—
+8K172522Mazor XMazor Robotics, Ltd.20170—
+8K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+8K170360NAVIOBlue Belt Technologies, Inc.201717—
+8K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+8K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+8K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+8K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+8K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+8K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+8K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+8K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+9K260546Q Pedicle InstrumentsK2m, Inc.20260—
+9K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+9K252873Q Interbody InstrumentsK2m, Inc.20260—
+9K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+9K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+9K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+9K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+9K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+9K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+9K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+9K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+9K233017TM Plating SystemTyber Medical, LLC20231—
+9K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+9K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+9K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+9K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+9K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+9K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+9K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+9K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+9K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+9K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202307Activ FuseNewclip Technics20200—
+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—
+9K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+9K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+9K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+9K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+9K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+9K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+9K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+9K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+9K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+10K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+10K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+10K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+10K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+10K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+10K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+10K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+10K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+10K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+10K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—