510(k) Report

Devices descending from K172462

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+1K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+1K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+2K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+2K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+2K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+2K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+3K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502