510(k) Report

Devices descending from K171780

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242616Lantern® HipOrthalign, Inc.20241—
+1K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+1K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+2K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+2K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+2K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+2K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+3K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+3K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+3K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+3K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+4K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502