510(k) Report

Devices descending from K050615

29 later devices reach Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203751OMNIVision systemCorin USA20210—
+1K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+1K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+2K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+2K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+2K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+2K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+3K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+3K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+3K242616Lantern® HipOrthalign, Inc.20241—
+3K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+3K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+3K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+4K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+4K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+4K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+4K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+5K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+5K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+5K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+5K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+5K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+6K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+6K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+6K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+7K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—