Neurological Stereotaxic Instrument
FDA product code HAW · Class II (moderate risk) · 21 CFR 882.4560 · Neurology
425510(k) clearances
0PMA approvals
189recalls
Manufacturers
- Brainlab AG 59
- Medtronic Navigation, Inc. 19
- Elekta Instrument AB 16
- Image-Guided Neurologics, Inc. 15
- Surgical Navigation Technologies, Inc. 15
- Orthosoft, Inc. 12
- Medtronic Surgical Navigation Technologies 11
- Radionics, Inc. 11
- ClearPoint Neuro, Inc. 10
- Smith & Nephew, Inc. 8
- Stryker Corporation 8
- Philips Medical Systems (Cleveland) Inc 7
- Stryker Instruments 6
- FHC, Inc. 6
- Radionics Software Applications, Inc. 6
- Mazor Surgical Technologies , Ltd. 5
- Z-Kat, Inc. 5
- Medtech S.A 5
- Zimmer, Inc. 5
- Ohio Medical Instrument Co., Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…HAW · Traditional | Brainlab AG | 01/28/2025SE |
| K243657 | ClearPoint System (Software Version 3.0)HAW · Traditional | ClearPoint Neuro, Inc. | 01/24/2025SE |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 01/17/2025SE |
| K242480 | FLASH EVD System (10-0002)HAW · Traditional | 7D Surgical ULC | 12/27/2024SE |
| K242351 | Zeta Cranial Navigation System (ZNS131-US)HAW · Special | Zeta Surgical, Inc. | 10/04/2024SE |
| K233703 | Bone Anchor (NGS-BA-01)HAW · Traditional | ClearPoint Neuro, Inc. | 04/26/2024SE |
| K233155 | ClearPointer Optical Navigation WandHAW · Traditional | ClearPoint Neuro, Inc. | 01/12/2024SE |
| K233144 | ClearPoint Bone Screw FiducialsHAW · Traditional | ClearPoint Neuro, Inc. | 01/12/2024SE |
| K233141 | SmartFrame ORHAW · Traditional | ClearPoint Neuro, Inc. | 01/12/2024SE |
| K233903 | Zeta Cranial Navigation System (ZNS131-US)HAW · Special | Zeta Surgical, Inc. | 01/10/2024SE |
| K233243 | ClearPoint System (Software Version 2.2)HAW · Traditional | ClearPoint Neuro, Inc. | 11/27/2023SE |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585)HAW · Traditional | Medtronic Navigation, Inc. | 10/19/2023SE |
| K232102 | ClearPoint Array System (Version 1.2)HAW · Special | ClearPoint Neuro, Inc. | 09/15/2023SE |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…HAW · Traditional | Brainlab AG | 09/09/2023SE |
| K230661 | Zeta Cranial Navigation SystemHAW · Traditional | Zeta Surgical | 09/08/2023SE |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…HAW · Traditional | Brainlab AG | 07/21/2023SE |
| K231103 | ROSA ONE Brain ApplicationHAW · Traditional | Medtech S.A.S | 07/20/2023SE |
| K231392 | NaviNetics Reusable Stereotactic System (NN1000)HAW · Traditional | Navinetics, Inc. | 07/14/2023SE |
| K220072 | Sinobot X1HAW · Traditional | Sinovation (Beijing) Medical Technology Co., Ltd. | 06/18/2023SE |
| K223552 | Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…HAW · Traditional | Brainlab AG | 04/19/2023SE |
| K223577 | Localite TMS Navigator TSHAW · Traditional | Localite GmbH | 04/17/2023SE |
| K221544 | MagVenture TMS Atlas Neuro Navigation SystemHAW · Traditional | Tonica Elektronik A/S | 03/17/2023SE |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0HAW · Special | PAJUNK GmbH Medizintechnologie | 02/22/2023SE |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…HAW · Traditional | Stryker Corporation | 02/16/2023SE |
| K222519 | ClearPoint SystemHAW · Special | ClearPoint Neuro, Inc. | 09/16/2022SE |
| K213989 | Cranial EM SystemHAW · Traditional | Brainlab AG | 09/08/2022SE |
| K220897 | Disposable Brain Biopsy Needle 2.0HAW · Traditional | PAJUNK GmbH Medizintechnologie | 08/17/2022SE |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4HAW · Traditional | Medtronic Navigation, Inc. | 06/10/2022SE |
| K214065 | ROSA ONE Brain applicationHAW · Traditional | Medtech S.A.S | 05/04/2022SE |
| K214040 | ClearPoint Array System (version 1.1)HAW · Traditional | ClearPoint Neuro, Inc. | 04/12/2022SE |
| K210109 | visor2 systemHAW · Traditional | Eemagine Medical Imaging Solutions GmbH | 04/08/2022SE |
| K212397 | StealthStation S8 Cranial v2.0HAW · Traditional | Medtronic Navigation | 12/22/2021SE |
| K201435 | Molecular Flow SimulationsHAW · Traditional | Therataxis, LLC | 12/03/2021SE |
| K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…HAW · Traditional | Brainlab AG | 11/12/2021SE |
| K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead LocalizationHAW · Traditional | Brainlab AG | 11/03/2021SE |
| K203251 | SOLOPASS SystemHAW · Traditional | Intravent Medical Partners, LP | 08/27/2021SE |
| K210700 | NaviNetics D1 Stereotactic SystemHAW · Traditional | Navinetics, Inc. | 06/17/2021SE |
| K201752 | Disposable Pre-calibrated SuctionHAW · Traditional | Brainlab AG | 01/29/2021SE |
| K202575 | ClearPoint Array SystemHAW · Traditional | ClearPoint Neuro, Inc. | 01/22/2021SE |
| K203639 | StealthStation Cranial Software v1.3.2HAW · Special | Medtronic Navigation, Inc. | 01/13/2021SE |
| K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…HAW · Traditional | Brainlab AG | 10/08/2020SE |
| K201175 | StealthStation Cranial Software v1.3.0HAW · Special | Medtronic Navigation, Inc. | 06/03/2020SE |
| K200511 | ROSA ONE Brain applicationHAW · Traditional | Medtech S.A | 05/29/2020SE |
| K191422 | Neural NavigatorHAW · Traditional | Soterix Medical, Inc. | 04/06/2020SE |
| K200079 | ClearPoint System and AccessoriesHAW · Special | Mri Interventions, Inc. | 02/13/2020SE |
| K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement ApplicationHAW · Special | 7D Surgical, Inc. | 11/27/2019SE |
| K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop SystemHAW · Traditional | Medtronic Navigation, Inc. | 11/01/2019SE |
| K190250 | Microscope NavigationHAW · Special | Brainlab AG | 09/06/2019SE |
| K183276 | 7D Surgical SystemHAW · Special | 7D Surgical, Inc. | 08/07/2019SE |
| K190887 | Leksell Vantage Stereotactic SystemHAW · Traditional | Elekta Instrument AB | 08/01/2019SE |
| K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1HAW · Traditional | Medtronic Navigation, Inc. | 07/31/2019SE |
| K183325 | Modus NavHAW · Traditional | Synaptive Medical, Inc. | 07/14/2019SE |
| K191400 | Voyager Trajectory Array Guide (V-TAG)HAW · Special | Mri Interventions, Inc. | 06/21/2019SE |
| K182417 | ROSA ONE Brain ApplicationHAW · Traditional | Medtech S.A | 02/07/2019SE |
| K182000 | AQrate Robotic Assistance SystemHAW · Traditional | Globus Medical, Inc. | 01/29/2019SE |
| K181041 | 7D Surgical System Cranial ApplicationHAW · Traditional | 7D Surgical, Inc. | 08/08/2018SE |
| K181706 | neuromate Gen IIIHAW · Special | Renishaw Mayfield Sarl | 07/26/2018SE |
| K180854 | Voyager Trajectory Array Guide (V-TAG)HAW · Traditional | Voyager Therapeutics, Inc. | 07/23/2018SE |
| K180206 | neuromate Gen IIIHAW · Traditional | Renishaw Mayfield Sarl | 04/24/2018SE |
| K172444 | ROSA BRAIN (v3.0.0.5)HAW · Traditional | Medtech S.A | 03/28/2018SE |
| K172820 | Microscope Navigation SoftwareHAW · Traditional | Brainlab AG | 03/01/2018SE |
| K171123 | Leksell Vantage Stereotactic SystemHAW · Traditional | Elekta Instrument AB | 09/15/2017SE |
| K163666 | neuro inspireHAW · Traditional | Rensihaw Plc | 09/15/2017SE |
| K163209 | Fiagon Navigation SystemHAW · Traditional | Fiagon GmbH | 09/14/2017SE |
| K163439 | NaviENTHAW · Traditional | Claronav, Inc. | 09/01/2017SE |
| K162655 | StealthConnect Remote Viewing, Planning and Collaboration SystemHAW · Traditional | Medtronic Navigation, Inc. | 04/21/2017SE |
| K162309 | StealthStation S8 System Platforms and StealthStation Cranial SoftwareHAW · Traditional | Medtronic Navigation, Inc. | 03/31/2017SE |
| K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap…HAW · Traditional | Stryker Corporation | 02/22/2017SE |
| K162604 | Cranial Reducing TubesHAW · Traditional | Medtronic Navigation, Inc. | 12/30/2016SE |
| K160811 | CRW Stereotactic SystemHAW · Abbreviated | Integra LifeSciences Corporation | 12/06/2016SE |
| K153660 | StealthStation System with Cranial SoftwareHAW · Traditional | Medtronic Navigation, Inc. | 09/14/2016SE |
| K152764 | Exactech GPSHAW · Traditional | Blue Ortho | 07/13/2016SE |
| K160523 | BrightMatter Guide with BrightMatter PointerHAW · Traditional | Synaptive Medical, Inc. | 06/24/2016SE |
| K151156 | Fiagon Navigation SystemHAW · Traditional | Fiagon GmbH | 04/01/2016SE |
| K153281 | BrightMatter Guide with Surface Trace RegistrationHAW · Traditional | Synaptive Medical, Inc. | 03/30/2016SE |
| K160434 | ClearPoint SystemHAW · Special | Mri Interventions, Inc. | 03/17/2016SE |
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle KitHAW · Special | Elekta Instrument AB | 03/02/2016SE |
| K151359 | ROSA BrainHAW · Traditional | Medtech S.A | 12/18/2015SE |
| K143420 | SYMBIS Surgical SystemHAW · Traditional | Imris, Inc. | 10/30/2015SE |
| K142505 | ClearPoint SystemHAW · Traditional | Mri Interventions, Inc. | 10/21/2015SE |
| K150301 | NavSuite3 KitHAW · Special | Stryker Leibinger GmbH & Co. KG - Navigation | 07/08/2015SE |
| K150216 | Synergy CranialHAW · Traditional | Medtronic Navigation, Inc. | 06/11/2015SE |
| K143241 | MDT Navigable Brain Biopsy CannulaHAW · Traditional | Izi Medical Products, LLC | 04/13/2015SE |
| K142024 | Brightmatter Navigation SystemHAW · Traditional | Synaptive Medical, Inc. | 04/02/2015SE |
| K141833 | Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer…HAW · Traditional | Medtronic Navigation, Inc. | 03/25/2015SE |
| K142344 | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation SystemHAW · Traditional | Izi Medical Products, LLC | 03/20/2015SE |
| K141559 | V-Guide for VentriculostomiesHAW · Traditional | Arc Surgical, LLC | 02/27/2015SE |
| K140705 | Navigable Brain Biopsy Cannula SetHAW · Traditional | Izi Medical Products | 12/05/2014SE |
| K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation SystemHAW · Traditional | Medtronic Navigation, Inc. | 07/25/2014SE |
| K140868 | Stryker Kwic NeedleHAW · Traditional | Orthovita, Inc. | 06/05/2014SE |
| K132755 | Neuromate Frameless Gen IIHAW · Traditional | Renishaw Mayfield Sarl | 04/29/2014SE |
| K132611 | Microtable SystemHAW · Traditional | Fred Haer Company, Inc. | 03/06/2014SE |
| K131214 | Cranial Map NeuroHAW · Traditional | Stryker Corporate | 10/18/2013SE |
| K130874 | Stryker NAV3I PlatformHAW · Traditional | Stryker Corporate | 09/27/2013SE |
| K130608 | QuadcutHAW · Traditional | Medtronic Navigation, Inc. | 08/07/2013SE |
| K122211 | Synthes Navigable Pedicle Preparation InstrumentsHAW · Traditional | Synthes Spine | 12/17/2012SE |
| K122096 | Karl Storz Navigationpanel Unit (Npu) SystemHAW · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/27/2012SE |
| K121950 | Microtargeting XL Star Drive SystemHAW · Special | FHC, Inc. | 07/26/2012SE |
| K120812 | RenaissanceHAW · Traditional | Mazor Robotics , Ltd. | 07/12/2012SE |
| K110644 | Praezis PlusHAW · Traditional | Tatramed Spol. S.R.O. | 05/24/2012SE |
| K112094 | Brain Biopsy NeedleHAW · Traditional | Ad-Tech Medical Instrument Corp | 04/24/2012SE |
| K111558 | Surgicase GuideHAW · Traditional | Materialise NV | 03/27/2012SE |
| K112469 | General Prupose Localizers and Adapters-New Accessories for Sonowand SystemHAW · Traditional | Sonowand AS | 03/23/2012SE |
| K113228 | Renaissance SystemHAW · Special | Mazor Robotics , Ltd. | 12/01/2011SE |
| K101627 | IplanHAW · Traditional | Brainlab AG | 06/03/2011SE |
| K110911 | Renaissance SystemHAW · Special | Mazor Robotics , Ltd. | 04/28/2011SE |
| K103192 | Navigation Marker, Reflective Marker SpheresHAW · Traditional | Ilumark GmbH | 02/07/2011SE |
| K101791 | Rosa Surgical DeviceHAW · Traditional | Medtech S.A.S | 09/23/2010SE |
| K102130 | Tenzing SystemHAW · Special | Mazor Surgical Technologies , Ltd. | 08/26/2010SE |
| K100038 | Disposable Reflective Marker SpheresHAW · Traditional | Brainlab AG | 07/14/2010SE |
| K092467 | Vectorvision Cranial, Vectorvision ENT, Kolibri Cranial, Kolibri ENT, Cranial Essential…HAW · Special | Brainlab AG | 05/06/2010SE |
| K100314 | Imns Medacta Navigation SYSTEM,33.221000USHAW · Special | Medacta International S.A. | 03/31/2010SE |
| K092192 | Waypoint Stereotactic SystemHAW · Traditional | FHC, Inc. | 02/12/2010SE |
| K092239 | Rosa Surgical Device, Model Rosa 1.1HAW · Traditional | Medtech S.A | 11/17/2009SE |
| K090190 | Win-Neus Stereotactic Surgery Treatment Planning SystemHAW · Traditional | Nuclemed S.A. | 10/09/2009SE |
| K083597 | Sonowand InviteHAW · Traditional | Sonowand AS | 09/25/2009SE |
| K092562 | Microtargeting Star Drive System, ComponentsHAW · Special | FHC, Inc. | 09/18/2009SE |
| K090240 | Monteris Medical UfoHAW · Traditional | Monteris Medical, | 08/06/2009SE |
| K082060 | Cranial Image Guided Surgery SystemHAW · Traditional | Brainlab AG | 05/08/2009SE |
| K080355 | Leksell Stereotactic System with Reusable Fixation ScrewsHAW · Traditional | Elekta Instrument AB | 05/01/2009SE |
| K083565 | Pigalileo Total Hip Replacement (THR) Software Application V3.0HAW · Special | Smith & Nephew, Inc. | 02/20/2009SE |
| K081867 | Mako Surgical Tactile Guidance System Version 2.0HAW · Traditional | Mako Surgical Corp. | 11/25/2008SE |
| K082267 | Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1HAW · Special | Smith & Nephew, Inc. | 10/29/2008SE |
| K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited Ci Knee, Ci Knee UnlimitedHAW · Traditional | Brainlab AG | 09/05/2008SE |
| K081232 | Total Knee Surgetics Navigation System with PraxitelesHAW · Traditional | Praxim | 08/06/2008SE |
| K080875 | Pigalileo 4TH Generation SystemHAW · Abbreviated | Smith & Nephew, Inc. | 07/18/2008SE |
| K080450 | Stryker Power Tool Navigator AttachmentHAW · Traditional | Stryker Corp. | 07/17/2008SE |
| K080678 | Uni-Knee 2.0HAW · Traditional | Brainlab AG | 06/06/2008SE |
| K080547 | Orthopilot Next Generation, Model FS101-FS106HAW · Special | Aesculap Implant System, Inc. | 05/23/2008SE |
| K073467 | Spineassist SystemHAW · Traditional | Mazor Surgical Technologies , Ltd. | 05/23/2008SE |
| K080250 | Leksell Surgiplan, Model 1006947HAW · Special | Elekta Instrument AB | 05/13/2008SE |
| K072899 | Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0HAW · Special | Aesculap Implant Systems, Inc. | 02/06/2008SE |
| K072806 | Mako Surgical Tactile Guidance System (TGS)HAW · Traditional | Mako Surgical Corp. | 01/24/2008SE |
| K072271 | Stryker Navigation System Infinitus Hip Resurfacing ModuleHAW · Traditional | Stryker Corp. | 12/18/2007SE |
| K072267 | Total Hip Surgetics Navigation SystemHAW · Traditional | Praxim S.A | 12/10/2007SE |
| K072716 | Vector Vision HipHAW · Special | Brainlab AG | 10/12/2007SE |
| K072573 | Vectorvision Hip and Hip SRHAW · Special | Brainlab AG | 10/11/2007SE |
| K070556 | Brainsuite NetHAW · Traditional | Brainlab AG | 09/25/2007SE |
| K071929 | Navitrack System- Partial Hip Resurfacing UniversalHAW · Traditional | Orthosoft, Inc. | 09/19/2007SE |
| K063607 | Spineassist SystemHAW · Traditional | Mazor Surgical Technologies , Ltd. | 08/23/2007SE |
| K070731 | Pigalileo Total Hip Replacement (THR) SystemHAW · Traditional | Plus Orthopedics AG | 07/31/2007SE |
| K071714 | Navitrack System - Os Unicondylar Knee Universal, Model# PRO-06003HAW · Special | Orthosoft, Inc. | 07/20/2007SE |
| K071334 | Depuy Cas Hemi Asr Hip InstrumentsHAW · Traditional | DePuy Orthopaedics, Inc. | 07/02/2007SE |
| K071135 | Depuy Ci Hip InstrumentationHAW · Special | DePuy Orthopaedics, Inc. | 05/23/2007SE |
| K070106 | VV Fluoro 3DHAW · Traditional | Brainlab AG | 04/23/2007SE |
| K061479 | ArgosHAW · Traditional | 3D Line Medical Systems S.R.L. | 04/05/2007SE |
| K063408 | Ctlogics Navigations SystemsHAW · Traditional | Praxim Medivision, SA | 02/28/2007SE |
| K062358 | Modification to Vectorvision TraumaHAW · Special | Brainlab AG | 01/17/2007SE |
| K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000HAW · Traditional | Stryker Instruments | 12/14/2006SE |
| K063028 | Vectorvision Hip SRHAW · Traditional | Brainlab AG | 12/12/2006SE |
| K062228 | Zimmer Hip Computer Assisted Solutions Electromagnetic and Imageless InstrumentationHAW · Traditional | Zimmer, Inc. | 11/08/2006SE |
| K061362 | Pigalileo Total Knee Replacement (TKR) SystemHAW · Traditional | Plus Orthopedics AG | 10/06/2006SE |
| K062086 | NavivisionHAW · Traditional | Brainlab AG | 09/20/2006SE |
| K061224 | Lapdoc IHAW · Traditional | Robodent GmbH | 09/05/2006SE |
| K061248 | Axiem Imageless Hip Module for the Stealthstation SystemHAW · Traditional | Medtronic Navigation, Inc. | 08/31/2006SE |
| K062146 | Uni Knee Surgetics Navigation SystemHAW · Special | Praxim S.A | 08/21/2006SE |
| K060727 | Vectorvision HipHAW · Special | Brainlab AG | 08/21/2006SE |
| K053348 | Stryker Orthopaedics Rfid InstrumentationHAW · Traditional | Howmedica Osteonics Corp. | 08/04/2006SE |
| K060556 | Brigit Surgical DeviceHAW · Traditional | Zimmer, Inc. | 07/31/2006SE |
| K060808 | Brainpro, Brainpro AccessHAW · Traditional | PAJUNK GmbH Medizintechnologie | 07/25/2006SE |
| K053159 | Vectorvision SpineHAW · Traditional | Brainlab AG | 06/06/2006SE |
| K060336 | Navitrack System-Os Knee Universal, Model PRO-05002HAW · Special | Orthosoft, Inc. | 04/28/2006SE |
| K060282 | Total Knee Surgetics Navigation SystemHAW · Special | Praxim S.A | 04/10/2006SE |
| K053542 | Surgetics Ortho Osteologics Navigation SystemHAW · Traditional | Praxim S.A | 04/10/2006SE |
| K053164 | Iplan FlowHAW · Traditional | Brainlab AG | 03/23/2006SE |
| K060121 | Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip ApplicationsHAW · Traditional | Biomet Manufacturing Corp | 03/21/2006SE |
| K060468 | Vectorvision HipHAW · Special | Brainlab AG | 03/20/2006SE |
| K052623 | Imageless Hip Module for the Stealthstation SystemHAW · Special | Medtronic Navigation, Inc. | 03/02/2006SE |
| K052966 | Ci Knee, Ci Mi TKRHAW · Traditional | Brainlab AG | 02/13/2006SE |
| K053127 | IplanHAW · Traditional | Brainlab AG | 02/09/2006SE |
| K052425 | Zimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee InstrumentationHAW · Traditional | Zimmer, Inc. | 12/28/2005SE |
| K052840 | Igi-SystemHAW · Traditional | Denx Advanced Dental Systems | 12/16/2005SE |
| K051734 | GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin…HAW · Traditional | Ge Healthcare Technologies | 11/23/2005SE |
| K052851 | Voyager Linux with Tactile Guidance System (TGS)HAW · Special | Mako Surgical Corp. | 11/18/2005SE |
| K052213 | Navigation SW Hip 3.1 on CiHAW · Special | Brainlab AG | 11/02/2005SE |
| K052178 | Depuy Cas Hip InstrumentationHAW · Traditional | DePuy Orthopaedics, Inc. | 10/21/2005SE |
| K051676 | Spineassist Device with Additional AccessoriesHAW · Traditional | Mazor Surgical Technologies , Ltd. | 09/08/2005SE |
| K050651 | Medtronic Orthopaedic Trauma ApplicationHAW · Traditional | Medtronic Navigation, Inc. | 07/27/2005SE |
| K051746 | Elekta Esarte Frame SystemHAW · Special | Elekta Instrument AB | 07/25/2005SE |
| K051724 | Acumen Image Guided Surgical SystemHAW · Traditional | Ebi, L.P. | 07/19/2005SE |
| K051029 | Stelthstation Wireless Surgeon MouseHAW · Special | Medtronic Surgical Navigation | 06/08/2005SE |
| K031196 | Surgetics Ortho Kneelogics Navigation SystemHAW · Traditional | Praxim | 06/07/2005SE |
| K050438 | Stealthstation System UpdateHAW · Special | Medtronic Surgical Navigation Technologies | 06/02/2005SE |
| K041897 | Mayfield Acciss II Image Guided Surgery System, Model 2002-01HAW · Traditional | Schaerer Mayfield USA, Inc. | 06/01/2005SE |
| K050897 | Navipro Shoulder Software ModuleHAW · Traditional | Kinamed, Inc. | 05/24/2005SE |
| K050973 | Modification to: Voyager LinuxHAW · Special | Mako Surgical Corp. | 05/17/2005SE |
| K042543 | Iplan! Digital TemplatingHAW · Traditional | Brainlab AG | 05/17/2005SE |
| K050752 | Aesculap Orthopilot 2 Tha V 2.0HAW · Special | Aesculap, Inc. | 04/27/2005SE |
| K050772 | Navigus Reusable Passive Probe, Model SP-2000HAW · Traditional | Image-Guided Neurologics, Inc. | 04/21/2005SE |
| K050615 | Stryker Navigation System - Ct-Based Hip Module, Model 6007-621-000HAW · Special | Stryker Instruments | 04/21/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2006-2026 Class II | Brand Name: Leksell Vantage Arc System REF: 1053958Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during… | Elekta, Inc. | 03/19/2026Open, Classified |
| Z-0963-2026 Class II | The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed…When the device is activated during surgery, the device software issues an error message "Instrument Face… | Howmedica Osteonics Corp. | 11/12/2025Open, Classified |
| Z-0433-2026 Class II | Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic…Due to increased risk that paint flakes from the engravings may separate from the device and there is the… | Elekta, Inc. | 09/30/2025Open, Classified |
| Z-0312-2025 Class I | microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to…A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed… | FHC, Inc. | 10/04/2024Open, Classified |
| Z-0227-2025 Class I | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933…Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of… | Elekta Instrument AB | 09/25/2024Open, Classified |
| Z-1776-2024 Class I | Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the…Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the… | Medtronic Navigation, Inc. | 03/26/2024Open, Classified |
| Z-1397-2024 Class I | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm…Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some… | Elekta Instrument AB | 03/15/2024Open, Classified |
| Z-1478-2024 Class II | NaviNetics Skull Anchor Key and Drill Kit, REF NN1215Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was… | Navinetics Inc | 02/26/2024Open, Classified |
| Z-0997-2024 Class II | Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and…Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have… | Globus Medical, Inc. | 12/11/2023Open, Classified |
| Z-0996-2024 Class II | Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation…Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have… | Globus Medical, Inc. | 12/11/2023Open, Classified |
| Z-0995-2024 Class II | Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation…Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have… | Globus Medical, Inc. | 12/11/2023Open, Classified |
| Z-0188-2024 Class I | StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation…Due to a software anomaly which potentially could result in the surgical planning data shifting to an… | Medtronic Navigation, Inc. | 09/27/2023Open, Classified |
| Z-1666-2023 Class I | StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systemsIn nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized… | Medtronic Navigation, Inc. | 04/11/2023Open, Classified |
| Z-1630-2023 Class I | StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used…During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic… | Medtronic Navigation, Inc. | 04/11/2023Open, Classified |
| Z-1309-2023 Class II | Instructions for Use for the following Leksell Stereotactic System and Leksell…The incorrect IFU was distributed with the devices. | Elekta Instrument AB | 03/01/2023Open, Classified |
| Z-1039-2023 Class II | AxiEM" Non-Invasive Patient TrackerDue to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis… | Medtronic Navigation, Inc. | 12/15/2022Open, Classified |
| Z-0383-2022 Class I | Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or…Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized… | Medtronic Navigation, Inc. | 11/11/2021Open, Classified |
| Z-0417-2022 Class II | Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide…A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld… | Medtronic Navigation, Inc. | 11/09/2021Open, Classified |
| Z-0118-2022 Class I | ROSA One 3.1 Brain application The device is intended for the spatial positioning and…The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the… | Medtech SAS | 09/22/2021Open, Classified |
| Z-0157-2022 Class II | Medtronic sterile single-use blades that are components of the StraightShot M Series…There was an increase in complaints related to tip breaks and wobble/vibration. | Medtronic Xomed, Inc. | 08/31/2021Open, Classified |
| Z-0056-2021 Class II | Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT…Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. | Brainlab AG | 08/31/2020Terminated |
| Z-2442-2020 Class II | Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not… | Elekta Instrument AB | 06/10/2020Terminated |
| Z-2707-2020 Class II | StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product…There is a potential for specific camera units to be affected by a characterization issue during… | Medtronic Navigation, Inc. | 06/05/2020Terminated |
| Z-1826-2020 Class II | Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc…A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to… | Elekta Inc | 03/30/2020Terminated |
| Z-1151-2020 Class II | ROSA One 3.1 Brain ApplicationSome cross-sectional images from the image acquisitions of the patients head may not be… | Medtech SAS | 01/06/2020Terminated |
| Z-1150-2020 Class II | ROSA Brain 3.0 Application-BrainSome cross-sectional images from the image acquisitions of the patients head may not be… | Medtech SAS | 01/06/2020Terminated |
| Z-0659-2020 Class II | Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there… | Medtronic Navigation, Inc. | 10/30/2019Open, Classified |
| Z-0658-2020 Class II | Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there… | Medtronic Navigation, Inc. | 10/30/2019Open, Classified |
| Z-0657-2020 Class II | Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there… | Medtronic Navigation, Inc. | 10/30/2019Open, Classified |
| Z-0172-2020 Class I | Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case…The instrument holder may be sent on a trajectory that is not within the intended target. If it is not… | Medtech SAS | 09/10/2019Terminated |
| Z-1995-2020 Class I | Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0…Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may… | Medtronic Navigation, Inc. | 08/09/2019Terminated |
| Z-1082-2019 Class I | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine &…In certain occurrences, the affected navigation software application might unexpectedly display a navigated… | Brainlab AG | 02/27/2019Terminated |
| Z-0470-2019 Class I | BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product…This recall has been initiated due to a software defect found in the Guide System software when used with… | Synaptive Medical Inc | 10/09/2018Terminated |
| Z-0552-2019 Class I | StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical…An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial… | Medtronic Navigation, Inc. | 09/26/2018Terminated |
| Z-2359-2018 Class II | microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2358-2018 Class II | microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number…The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2357-2018 Class II | microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number…The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2356-2018 Class II | microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2355-2018 Class II | microTargeting" Drive System Distributed by Medtronic, Product Number FC1006The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2354-2018 Class II | microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DBThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2353-2018 Class II | microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DBThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2352-2018 Class II | microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-METhe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2351-2018 Class II | microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MAThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2350-2018 Class II | microTargeting" STar" Drive System (Motorized), Product Number ST-DS-METhe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2349-2018 Class II | microTargeting" STar" Drive System (Manual), Product Number ST-DS-MAThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2348-2018 Class II | microTargeting" Drive System, Product Number 66-ZD-MD-01The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2347-2018 Class II | microTargeting" Drive System, Product Number 66-ZD-MDThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2346-2018 Class II | microTargeting" Drive System, Product Number MT-DS-01The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2345-2018 Class II | microTargeting" Drive System, Product Number MT-DSThe FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is… | FHC, Inc. | 05/10/2018Terminated |
| Z-2108-2018 Class II | ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a…Replacement of units lacking an updated device approval. | Medtech SAS | 05/08/2018Terminated |