510(k) Report

Devices descending from K093998

40 later devices reach Kneealign System with Reference Sensor through their predicates, nearest generation first.

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