510(k) Report

Devices descending from K003347

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+7K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+7K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+7K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+7K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+7K152574NavioBlue Belt Technologies, Inc.201519—
+7K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+7K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+7K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+7K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+7K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+8K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243975Knee+Pixee Medical20253—
+8K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+8K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+8K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K242616Lantern® HipOrthalign, Inc.20241—
+8K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233299ExactechGPS® SystemBlue Ortho20240—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+8K231018Yomi Robotic SystemNeocis, Inc.20232—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+8K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+8K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+8K221028SURGIVISIO DeviceEcential Robotics20227—
+8K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+8K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+8K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+8K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+8K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+8K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+8K192173ROSA ONE Spine applicationMedtech S.A20190—
+8K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K182417ROSA ONE Brain ApplicationMedtech S.A201913Class I
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+8K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+8K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+8K172886Breakaway Screw SystemParagon 2820174—
+8K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+8K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+8K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+8K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+8K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+8K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+8K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+8K160537NavioBlue Belt Technologies, Inc.201618—
+8K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K253805Knee+Pixee Medical S.A.S.20260—