510(k) Report

Devices descending from K153237

18 later devices reach OrthAlign Plus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+1K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+2K192653PerseusOrthokey Italia S.R.L.20200—
+2K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+2K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+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—
+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—
+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—
+6K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502