510(k) Report

Devices descending from K130387

31 later devices reach Orthoalign Plus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+1K140331Orthalign Plus SystemOrthalign, Inc.201429—
+2K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+2K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+2K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+2K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+3K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+3K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+3K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+4K192653PerseusOrthokey Italia S.R.L.20200—
+4K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+4K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+4K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+5K242616Lantern® HipOrthalign, Inc.20241—
+5K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+5K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+5K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+6K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+6K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+6K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+6K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+7K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+7K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+7K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+7K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+7K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+7K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+7K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+8K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+8K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+9K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—