510(k) Report

Devices descending from K052966

54 later devices reach CI Knee, CI MI TKR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073615Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedBrainlab AG200852—
+1K080678Uni-Knee 2.0Brainlab AG20081—
+2K220652Knee 3Brainlab AG20220—
+2K102251Dash KneeBrainlab AG201110—
+2K102990Brainlab KneeBrainlab AG201171
+2K093118Brainlab Knee ArthroscopyBrainlab AG20100—
+2K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+2K091411Kneealign SystemOrthalign, Inc.200941—
+3K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+3K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K103829Kneealign SystemOrthalign, Inc.201139—
+4K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+4K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+4K193307HIP7Brainlab AG20200—
+4K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+4K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+4K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+4K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+4K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+4K122326Smarttools Knee SystemZimmer201232
+5K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+5K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+5K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+5K232140OTS HipOrtoma AB202421
+5K223351Naviswiss KneeNaviswiss AG20230—
+5K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+5K192653PerseusOrthokey Italia S.R.L.20200—
+5K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+5K141601Iassist Knee SystemZimmer Cas20142—
+5K140331Orthalign Plus SystemOrthalign, Inc.201429—
+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—
+6K250086OTS HipOrtoma AB202511
+6K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+6K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+6K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+6K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+7K261852OTS HipOrtoma AB20260—
+7K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+7K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+8K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+8K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+8K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+9K242616Lantern® HipOrthalign, Inc.20241—
+9K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+9K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+10K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+11K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+11K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+11K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+12K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+13K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—