Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instruments
Surgical navigation instruments
EMDN code Z120114
Manufacturers registered in Europe (EUDAMED) 31
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 396
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Astura Medical | United States | MASADA OLYMPIC ALTA REUNION | K240160 (2024) |
| XENIX MEDICAL LLC | United States | RIVA Posterior Fixation System RIVA Pedicle Screw System SOLACE Sacroiliac Fixation System Xenix Medical Sacroiliac Fixation System | registered |
| ALPHATEC SPINE, INC. | United States | Valence Robotic Navigation System Invictus Arsenal ATEC Posterior Navigation Disc Prep Instruments ATEC Lateral Navigation Disc Prep Instruments Illico | K252597 (2026) |
| Mazor Robotics , Ltd. Present in Europe in other categories | Israel | SA Reduction Tube, 10 pack 4mm x 120mm Schanz Screw, Qty: 10 SA 3.0mm Short Drill, 10 pack Brain Disposable Kit Drill Guide Anchor, 10 pack Arm 4 | K251316 (2025) |
| Seaspine Orthopedics Corporation | United States | Mariner MIS Mariner Deformity Specials Navigation Instruments Virata NorthStar | K243659 (2025) |
| Genesys Orthopedics Systems LLC | – | SIros-X SIros-O Sacroiliac Joint Fusion System Sacroiliac Joint Fusion System | registered |
| FHC, Inc. Present in Europe in other categories | United States | microTargeting™ Insertion Tube with Stylet microTargeting™ Insertion Tube microTargeting™ Insertion Tube Set microTargeting™ Platform microTargeting™ Spacer Tube STar™ Drive Frame Adapter | K121950 (2012) |
| VB Spine LLC | United States | Q Pedicle Instruments Navigation Instruments Q Interbody Instruments Navigated Spine Instruments Brainlab Compatible K2M Navigation Instruments | registered |
| Medos International Sàrl Present in Europe in other categories | Switzerland | ROBOTIC INTEGRATION INSTRUMENTS CROSSNAV CONDUIT TRIALTIS VELYS SYMPHONY | K254157 (2026) |
| Orthalign, Inc. Present in Europe in other categories | United States | OrthAlign Plus KneeAlign 2 Lantern Surgical Assistant Lantern Lantern Surgical Assistant (LSA) Harvey Surgical Assistant (HSA) | K200892 (2020) |
| Elekta Instrument AB | Sweden | Leksell Stereotactic System Leksell Vantage Stereotactic System Leksell Stereotactic System Neurosurgical Instruments Leksell Gamma Knife Perfexion/Icon | K190887 (2019) |
| PMT CORPORATION | United States | PMT CORPORATION - STEREOTACTIC STEREOTACTIC PMT CORPORATION ACCUNAV® | registered |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | PiGalileo TKR ACHIEVECAS PROFIX PIGALILEO Real Intelligence Navio | K180277 (2018) |
| Mako Surgical Corp. Present in Europe in other categories | United States | Mako RIO ACCOLADE II RESTORIS, RIO RESTORIS, PST, RIO | K260222 (2026) |
| Orthosoft, Inc. Present in Europe in other categories | Canada | Sesamoid NavitrackER Polaris ROSA® Shoulder ROSA® ROSA® Knee | K100599 (2010) |
| SPINAL ELEMENTS, INC. | United States | OVERWATCH SAVANNAH Primus MERCURY | K190881 (2019) |
| Medtech S.A Present in Europe in other categories | France | MAYFIELD HEAD HOLDER ADAPTOR STORZ 28160 G ADAPTOR SEEG SST DRILL ADAPTOR Ø3.2MM SEEG SST DRILL ADAPTOR Ø2.15MM LEKSELL FRAME REGISTRATION PLATES SEEG SST DRILL ADAPTOR Ø2.55MM | K231103 (2023) |
| Exactech, Inc. | United States | EXACTECHGPS Truliant GPS Equinoxe ExactechGPS Ankle Application Newton | registered |
| Omni Life Science, Inc. Present in Europe in other categories | – | OMNIBotics | registered |
| icotec AG | Switzerland | CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 14 mm CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 r120 - 80 mm CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 28 mm CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 22 mm CMORE® System, Screwdriver Shaft, T15 CMORE® System, Rod Cutter | K230861 (2023) |
| Elekta Solutions AB Present in Europe in other categories | Sweden | Leksell Stereotactic System Leksell Vantage Stereotactic System | K261932 (2026) |
| Izi Medical Products, LLC Present in Europe in other categories | United States | Snap On Spherz Threaded Spherz Quick Spherz Navigated Brain Biopsy Cannula Disposable Passive Array - Blunt Probe DISP DYNAMIC REFERENCE FRAME | K143241 (2015) |
| Highridge Medical, LLC | United States | Vital MIS Spinal Fixation System LineSider Vital Navigation System Universal Navigation System Virage Navigation System | registered |
| Orthofix US LLC Present in Europe in other categories | United States | FIREBIRD NXG POCT,NAVIGATED INSTRUMENTS NAVIGATED INSTRUMENTS;FIREBIRD NXG NAVIGATED INSTRUMENTS;PHOENIX SFS NAVIGATED INSTRUMENTS,PHOENIX SFS Firebird SI Navigation System FIREBIRD NXG POCT | K252088 (2025) |
| KOH YOUNG TECHNOLOGY INC. | South Korea | Geniant Cranial | K253856 (2026) |
| CARBOFIX ORTHOPEDICS LTD | Israel | CarboClear X Pedicle Screw System CarboClear Pedicle Screw Systems CarboClear Pedicle Screw System | K201251 (2020) |
| Point Robotics MedTech, Inc. | Taiwan | POINT ROBOTICS MEDTECH INC. | K252989 (2026) |
| Integra LifeSciences Corporation Present in Europe in other categories | United States | CRW® Integra® Integra® Luminant® CRW® Precision CRW™ | K160811 (2016) |
| PRECISION SPINE, INC. | United States | Navigated Instrument System E-GPS Navigated Instrument System GM Navigated Instrument System | K231229 (2023) |
| Intellijoint Surgical, Inc. | Canada | intellijoint HIP® intellijoint KNEE® Intellijoint Navigation System intellijoint HIP (R) intellijoint KNEE (R) Intellijoint KNEE(R) | K191507 (2019) |
| Spine Wave, Inc. | United States | Proficient® Posterior Cervical Spine System Salvo® XRS Robotic Navigation Instrument System Sniper® Spine System CapSure® Spine System Salvo® Spine System Salvo® Robotic Navigation Instruments | K243514 (2025) |
| ZIMMER BIOMET INC | – | Vital™ Navigation System Vital MIS - Universal Navigation Virage Navigation System Universal Adapters for Navigation Vital Navigation | registered |
| Xtant Medical Holdings, Inc. | United States | Cortera Streamline | registered |
| SI-BONE, Inc. Present in Europe in other categories | United States | iFuse Navigation Tracking System Granite iGPS 6.5mm Awl Tip Tap Navigation - Impactor, Tube & Mount TORQ iGPS 8.5mm Awl Tip Tap TORQ TNT Exchange Tube Trocar Pin, 2.5 mm x 330 mm | K251780 (2025) |
| Neocis, Inc. | United States | Neocis Guidance System YomiLink Arch (LLUR) Yomi S YomiLink Arch LLUR YLB-IOFA- Large Yomi S Extra Oral Fiducial Array LRUL YomiLink Bone (LR) | K261321 (2026) |
| NEXXT SPINE, LLC | United States | Nexxt Spine Navigation System | K220291 (2022) |
| Corin USA Present in Europe in other categories | United States | Apollo Knee | K231172 (2023) |
| Tyber Medical, LLC Present in Europe in other categories | United States | Anatomic Access LLIF | K261060 (2026) |
| Synthes GmbH Present in Europe in other categories | United States | – | registered |
| ORTHOPEDIATRICS CORP. Present in Europe in other categories | United States | Response Navigation VerteGlide Spinal Growth Guidance System Naviagtion Instrumentation | K203573 (2021) |
| ClearPoint Neuro, Inc. Present in Europe in other categories | United States | SmartFrame ClearPoint SmartFrame OR SmartFrame Array SMARTFrame Expanded Accessory Kit, 5 Fr ClearPoint Array | K243657 (2025) |
| CAMBER SPINE TECHNOLOGIES, LLC | United States | Navigation Instrument | K220038 (2022) |
| CTL Medical Corporation | United States | CTL Amedica NAVIGATION Instruments GENERIC Surgical Instruments | K213491 (2022) |
| THINK Surgical, Inc. | United States | Tsolution One Surgical System TMINI® Guide Block Kit compatible with Stryker® Triathlon® Knee System (10ea) TPLAN® Planning Station TMINI® Guide Block Kit for United® U2™ Knee (10ea) TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee TMINI® Guide Block Kit for Zimmer Biomet: Posterior Referencing Persona® Knee | K263234 (2026) |
| Compass Intl., Inc. | United States | Compass International Compass COMPASS CYGNUS-PFS IGS System COMPASS Stereotactic Retractor System COMPASS Stereotactic System COMPASS CT Adaptation Stereotactic System | K964229 (1997) |
| Karl Storz GmbH & Co. KG Present in Europe in other categories | Germany | n.a. NAV1 | registered |
| Curiteva, Inc. | United States | Curiteva Navigation System | K223200 (2023) |
| Microport Navibot International LLC | United States | SkyWalker | K213873 (2022) |
| SPINECRAFT, LLC | United States | ASTRA Spine System ASTRA-OCT Spine System APEX Spine System AVANT | K223301 (2023) |
| INTAI TECHNOLOGY CORP. | Taiwan | WatchTower WatchTower ROAM WatchTower Navi Disposable Instrument Anatase Spine Surgery Navigation System | K180523 (2019) |
| Surgalign Spine Technologies, Inc. | United States | Cortera HOLO Portal HOLO Streamline | registered |
| Acclarent, Inc. | United States | TruDi Shaver Blade ACCLARENT PIVOT RELIEVA SPINPLUS NAV TruDi Probe TruDi NAV Suction TruDi NAVWIRE | K231862 (2023) |
| Globus Medical, Inc. Present in Europe in other categories | United States | EXCELSIUS GPS CREO | K182000 (2019) |
| Proprio, Inc. | United States | Paradigm Paradigm Navigated Drill Guide Case Lid Paradigm Depth Cannula, 5mm Paradigm Foot Switch Paradigm Navigated Drill Guide Case Assembly Paradigm Navigated Drill Guide Set | K252950 (2025) |
| Ulrich Medical Usa, Inc. Present in Europe in other categories | United States | Momentum Cortium Navigation | K252087 (2026) |
| Evolution Spine LLC | United States | Navigated Instruments | K250167 (2025) |
| Integrity Implants Inc. Present in Europe in other categories | United States | Accelus Navigated Reusable Instruments | K212088 (2021) |
| Eemagine Medical Imaging Solutions GmbH Present in Europe in other categories | Germany | tracking tools stimguide visor2 | K210109 (2022) |
| Localite GmbH | Germany | Localite TMS Navigator TS | K223577 (2023) |
| Renishaw Mayfield Sarl Present in Europe in other categories | France | neuromate tool guide neuromate - Tool guide neuromate planning station hardware neuro|mate® - Adaptation for Leksell Model G Elekta frame NMControl neuro|mate® - Tool-holder locking screw | K181706 (2018) |
| BIOMET SPINE LLC | – | Vital™ Vital™ Navigation System | registered |
| Ecential Robotics Present in Europe in other categories | France | CoBot, Drill Guide – Sleeve Op.n Core HDMI cable Op.n Core Op.n ChoiceSpine App CoBot, Spine Instruments tray CoBot, Drill Bit | K261113 (2026) |
| PATHKEEPER SURGICAL LTD | Israel | PKS DRF 4-ID9.5x8 PKS DRF 3-ID15 PathKeeper Surgical Accessories Kit PKS Patient Reference DRF S3D OTI Camera PKS Accessories Setup DRF | K222355 (2023) |
| Scopis GmbH | Germany | NOVA AR Registration pointer EM-D Instrument clamp forceps Patient tracker tabs (PU 100) Instrument port Instrument clamp 10-16 mm | K171661 (2017) |
| Spineology, Inc. | United States | Navigation OptiMesh Navigation Instruments Spineology Navigation Instruments | K251943 (2025) |
| CLARIANCE | France | ERISMA® LP_NAVIGATED INSTRUMENTS Erisma®-LP Navigated | K202956 (2021) |
| Northern Digital Inc Present in Europe in other categories | Canada | NDI Passive Spheres NDI Passive Sphere Disposable Reflective Marker Spheres (DRMS) Disposable Reflective Marker Sphere (DRMS) | K033621 (2004) |
| POLARISAR, INC. | United States | STELLAR Knee TruFix Pin Kit STELLAR Knee Marker Kit Right Femur - Left Tibia Arm Assembly Left Femur - Right Tibia Arm Assembly | registered |
| INNO Holdings, Inc. | United States | Excella® Navigation Navigation - Vector M-S Navigation - Vector™ G-E Excella Navigation | registered |
| Navinetics, Inc. | United States | NaviNetics Skull Anchor Key Kit NaviNetics MR Localizer Tubing Kit NaviNetics Ground Truth Fixture NaviNetics MR Localizer Kit NaviNetics Reusable Stereotactic Frame NaviNetics CT Localizer Kit | K231392 (2023) |
| Pixee Medical Present in Europe in other categories | France | KneePlus Slim Bone Reference KneeTools V5 Kit Universal Cutting Guide Left Proximal Cutting Guide Knee Stylus | registered |
| Synaptive Medical, Inc. Present in Europe in other categories | Canada | BrightMatter Guide Software Modus Nav Software Pointer Tool (SS) BrightMatter Patient Reference BrightMatter Guide Calibration Block BrightMatter Pointer Sterilizable Storage Tray | K183325 (2019) |
| Depuy, Inc. | United States | VELYS CUPTIMIZE Advanced VELYS PURESIGHT | registered |
| Medyssey Co., Ltd. | South Korea | Medyssey Navigation Instrument | K242806 (2025) |
| Nexstim Oyj Present in Europe in other categories | Finland | Nexstim NBS System Nexstim Head Tracker Tape Nexstim NBS software Nexstim NBS software GER Nexstim NBS Orange Head Tracker Nexstim NBT software | registered |
| DEGEN MEDICAL, INC. | United States | DeGen Navigated Instrumentation | K213918 (2022) |
| PROMETHEAN RESTORATIVE LLC | United States | DYNAMIS™ Navigation System | K252962 (2026) |
| Inomed Medizintechnik GmbH Present in Europe in other categories | Germany | – | registered |
| SurGenTec, LLC | United States | Ion Navigation Drill Bit - 5.0mm TiLink-L Navigation Drill Guide ION-C Navigation Drill Guide - Adjustable ION-C Navigation Reusable Tray Assembly Ion Navigation Drill Bit - 4.5mm TiLink-L Navigation Drill Bit - 8mm | K262121 (2026) |
| Ad-Tech Medical Instrument Corporation Present in Europe in other categories | United States | Disposable Brain Biopsy Needle Kit | K112094 (2012) |
| Sinovation (Beijing) Medical Technology Co., Ltd | China | – | K220072 (2023) |
| ENZTEC LIMITED | New Zealand | RI.KNEE Tibia Fixation Base Right RI.KNEE Tibia Cut Guide Right RI.KNEE Tibia Cut Guide Left RI.KNEE Tibia Fixation Base Left RI.KNEE Tibia Adjustment RI.KNEE Tracker Adapter | K230876 (2023) |
| Materialise NV Present in Europe in other categories | Belgium | ProPlan CMF | K111558 (2012) |
| Novarad Corporation Present in Europe in other categories | United States | VisAR | K220146 (2022) |
| DEPUY SPINE, LLC | United States | TRIALTIS Spine System CROSSNAV | registered |
| PAJUNK GmbH Medizintechnologie | Germany | Disposable Pre-calibrated Biopsy Needle Disposable Biopsy Needle BRAINPRO BRAINPRO STRYKER | K230201 (2023) |
| Augmedics, Ltd. | Israel | 8” Tablet 8” Tablet Docking Perc Pin Adaptor | registered |
| Biomet Orthopedics, LLC Present in Europe in other categories | United States | MIH CURVED ACETABULAR IMPACTER HANDLE SELEX INSERTER HANDLE STRAIGHT EXACT BROACH HANDLE | registered |
| DEPUY ORTHOPAEDICS, INC. Present in Europe in other categories | United States | CUPTIMIZE SIGMA | K071334 (2007) |
| GYDER SURGICAL PTY LTD | Australia | Single Use Kit Navigation Toolset Navigation Unit Kit | K243387 (2025) |
| Naviswiss AG | Switzerland | Control unit Tablet computer Navigation unit | K223351 (2023) |
| Zimmer, Inc. Present in Europe in other categories | United States | ROSA Comp Mini Reamer - Step 1 ROSA Comp Mini Reamer Assy Block ROSA Comp Mini Reamer - Step 2 | K122326 (2012) |
| BIOSENSE WEBSTER (ISRAEL) LTD. Present in Europe in other categories | – | TruDi™ Navigation System Carto ENT | registered |
| Bayer Medical Care Inc. Present in Europe in other categories | United States | Ball Joint Guide Array (BJGA)-Navigation Set Ball Joint Guide Array (BJGA)-Guide Set | K250893 (2025) |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | Diego | registered |
| Kalitec Direct LLC | – | NIDO Pedicle Screw System | registered |
| LEM Surgical AG | Switzerland | Dynamis Robotic Surgical System | K260369 (2026) |
| Lacey Manufacturing Company, LLC | – | Boston Endo Surgical Technologies LLC | registered |
| MEDTRONIC PS MEDICAL, INC. | United States | MR8 Stealth-Midas | registered |
| Navigate Surgical Technologies Inc | Canada | Inliant | K213392 (2022) |
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