510(k) Report

Devices descending from K022579

49 later devices reach Stryker Navigation System-Knee Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153240Styrker OrthoMap Express Knee SystemStryker Corporate201617—
+1K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Stryker Corporate201422—
+1K100742Exactech GPSBlue Ortho201020—
+2K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Stryker Leibinger GmbH & Co KG20231—
+2K221028SURGIVISIO DeviceEcential Robotics20227—
+2K183196Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers…Stryker Corporation20190—
+2K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Stryker Corporation201712—
+2K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG201616—
+2K152764Exactech GPSBlue Ortho2016191
+3K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+3K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+3K231886SURGIVISIO DeviceEcential Robotics20236—
+3K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG202210—
+3K213380360CASKico Knee Innovation Company Pty Limited20222—
+3K203205Navigated Spine InstrumentsStryker Spine20218—
+3K193618ExactechGPS SystemBlue Ortho202021
+3K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+4K260546Q Pedicle InstrumentsK2m, Inc.20260—
+4K252873Q Interbody InstrumentsK2m, Inc.20260—
+4K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K223927360CASKico Knee Innovation Company Pty Limited20231—
+4K213877ExactechGPS® SystemBlue Ortho20221—
+4K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+5K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+5K242009360CAS KneeKico Knee Innovation Company Pty, Ltd.20240—
+5K233299ExactechGPS® SystemBlue Ortho20240—
+5K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+5K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—