510(k) Report

Devices descending from K150301

18 later devices reach NavSuite3 Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153240Styrker OrthoMap Express Knee SystemStryker Corporate201617—
+2K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Stryker Leibinger GmbH & Co KG20231—
+2K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG201616—
+3K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+3K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG202210—
+3K213380360CASKico Knee Innovation Company Pty Limited20222—
+3K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Stryker Corporation201712—
+4K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+4K223927360CASKico Knee Innovation Company Pty Limited20231—
+4K203205Navigated Spine InstrumentsStryker Spine20218—
+5K260546Q Pedicle InstrumentsK2m, Inc.20260—
+5K252873Q Interbody InstrumentsK2m, Inc.20260—
+5K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+5K242009360CAS KneeKico Knee Innovation Company Pty, Ltd.20240—
+5K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+6K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+6K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+6K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—