510(k) Report

Devices descending from K091411

41 later devices reach Kneealign System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+2K103829Kneealign SystemOrthalign, Inc.201139—
+3K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+3K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+3K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+3K122326Smarttools Knee SystemZimmer201232
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+4K223351Naviswiss KneeNaviswiss AG20230—
+4K192653PerseusOrthokey Italia S.R.L.20200—
+4K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+4K141601Iassist Knee SystemZimmer Cas20142—
+4K140331Orthalign Plus SystemOrthalign, Inc.201429—
+5K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+5K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+5K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+5K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+5K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+6K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+6K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+7K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+7K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+7K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+8K242616Lantern® HipOrthalign, Inc.20241—
+8K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+8K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+8K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+9K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+9K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+9K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+9K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+10K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+10K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+10K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+10K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+10K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+10K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+10K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+11K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+11K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+12K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—