510(k) Report

Devices descending from K080547

22 later devices reach Orthopilot Next Generation, Model FS101-FS106 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090375Orthopilot Next Generation-Uka Software, Model FS210Aesculap Implant System, Inc.200921—
+2K153396Aesculap OrthoPilot Next GenerationAesculap Implant Systems, LLC20160—
+2K141694Aesculap Orthopilot Next GenerationAesculap Implant Systems, LLC201519—
+3K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+4K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+4K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+5K192653PerseusOrthokey Italia S.R.L.20200—
+5K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+5K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+6K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+6K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+6K242616Lantern® HipOrthalign, Inc.20241—
+6K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+6K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+7K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+7K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+7K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+8K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+8K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+8K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+8K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+9K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502