510(k) Report

Devices descending from K003347

436 later devices reach Orthopilot through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202100Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)Neocis, Inc.20200—
+5K192653PerseusOrthokey Italia S.R.L.20200—
+5K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+5K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+5K200348Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)Neocis, Inc.20200—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+5K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+5K182776Neocis Guidance SystemNeocis, Inc.20182—
+5K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+5K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+5K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K152764Exactech GPSBlue Ortho2016191
+5K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+5K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+5K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+5K141601Iassist Knee SystemZimmer Cas20142—
+5K140596NAVIOBlue Belt Technologies, Inc.201421—
+5K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+5K131130Navigation PinEvergreen Orthopedic Research Lab20130—
+5K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+5K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+5K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+5K101791Rosa Surgical DeviceMedtech S.A.S201012612
+5K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+5K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+5K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+6K253954X-Guide Surgical Navigation SystemX-Nav Technologies, LLC20260—
+6K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+6K250086OTS HipOrtoma AB202511
+6K243509Archer PSI System3D-Side20250—
+6K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+6K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K232176STELLAR KneePolarisar, Inc.20230—
+6K231172ApolloKneeCorin U.S.A. Limited20230—
+6K230789Knee+Pixee Medical20235—
+6K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+6K222049Yomi Robotic SystemNeocis, Inc.20224—
+6K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+6K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+6K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+6K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+6K193618ExactechGPS SystemBlue Ortho202021
+6K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc.20190—
+6K191605Neocis Guidance System (NGS)Neocis, Inc.20190—
+6K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+6K172522Mazor XMazor Robotics, Ltd.20170—
+6K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+6K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+6K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+6K151511ROSA SpineMedtech S.A20161093
+6K151359ROSA BrainMedtech S.A201520Class I
+6K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+6K143420SYMBIS Surgical SystemImris, Inc.20150—
+6K143668NavioBlue Belt Technologies, Inc.201520—
+6K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+6K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+6K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+6K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+6K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+6K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+6K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+6K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+6K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+7K261852OTS HipOrtoma AB20260—
+7K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+7K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+7K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+7K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+7K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+7K241470CORE Shoulder SystemLinkBio Corp.202501
+7K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+7K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+7K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+7K233899Knee+Pixee Medical20244—
+7K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+7K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K222750Yomi Robotic SystemNeocis, Inc.20223—
+7K213877ExactechGPS® SystemBlue Ortho20221—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+7K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+7K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+7K202307Activ FuseNewclip Technics20200—
+7K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+7K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+7K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+7K182848ROSA ONE Spine applicationMedtech S.A201910—
+7K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—