Instruments for functional explorations and therapeutic interventionsOrthopaedic instruments
Stereotactic orthopaedic surgery instruments
EMDN code Z121304
Manufacturers registered in Europe (EUDAMED) 6
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| MAKO Surgical FDA EU representative : Stryker European Operations Limited (Ireland) | United States | IIa MDR | Website EUDAMED record Report an error | |
| Navbit FDA EU representative : Emergo Europe B.V. (Netherlands) | Australia |
|
IIa MDR, 93/42 | Website EUDAMED record Report an error |
| Curexo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | South Korea | IIb MDR | EUDAMED record Report an error | |
| Ecential Robotics FDA | France |
|
IIb 93/42 | contact@ecential-robotics.com EUDAMED record Report an error |
| Mazor Robotics FDA EU representative : Medtronic B.V. (Netherlands) | Israel |
|
I, IIb MDR | EUDAMED record Report an error |
| Zimmer FDA EU representative : Biomet Global Supply Chain Center B.V. (Netherlands) | Canada | I MDR | Website EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 298
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) |
| Globus Medical, Inc. Present in Europe in other categories | United States | EXCELSIUS GPS EXCELSIUSGPS NAVIGATION INSTRUMENTS EXCELSIUSFLEX VERZERA CREO | K250599 (2025) |
| Nuvasive, Inc. Present in Europe in other categories | United States | PULSE ReLine NVM5 Excavation Bendini Remote Monitoring | K233706 (2024) |
| 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 |
| VB Spine LLC | United States | Q Pedicle Instruments Navigation Instruments Q Interbody Instruments Navigated Spine Instruments Brainlab Compatible K2M Navigation Instruments | registered |
| 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) |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | Real Intelligence Navio TRIGEN | K180277 (2018) |
| KICO KNEE INNOVATION COMPANY PTY LIMITED Present in Europe in other categories | Australia | ARVIS ® 360CAS | K242009 (2024) |
| SPINAL ELEMENTS, INC. | United States | OVERWATCH SAVANNAH Primus MERCURY | K190881 (2019) |
| Orthosoft, Inc. Present in Europe in other categories | Canada | ROSA® Shoulder ROSA® ROSA® Knee OptiVu™ Mixed Reality iASSIST® | K100599 (2010) |
| Stryker Leibinger GmbH & Co. KG Present in Europe in other categories | Germany | ORTHOMAP SPINEMAP NGENIUS SpineMap Go | K253623 (2026) |
| 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) |
| 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) |
| STRYKER CORPORATION Present in Europe in other categories | United States | RPS CORE CoPilot Q Navigation Enabled | K202749 (2020) |
| 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) |
| Exactech, Inc. | United States | GPS Equinoxe ExactechGPS Ankle Application Newton EXACTECHGPS | registered |
| SpineArt SA Present in Europe in other categories | Switzerland | PERLA NAV PERLA TL NAV-Instruments PERLA TL MIS NAV-Instruments PERLA TL Cortical NAV-Instruments PERLA ® INSTRUMENTATION ROMEO 2 MIS INSTRUMENTATION | K261205 (2026) |
| 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 |
| NEXXT SPINE, LLC | United States | Nexxt Spine Navigation System | K220291 (2022) |
| Tyber Medical, LLC Present in Europe in other categories | United States | Anatomic Access LLIF | K261060 (2026) |
| ORTHOPEDIATRICS CORP. Present in Europe in other categories | United States | Response Navigation VerteGlide Spinal Growth Guidance System Naviagtion Instrumentation | K203573 (2021) |
| 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) |
| 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 |
| 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) |
| Synthes GmbH Present in Europe in other categories | United States | – | registered |
| Ortoma AB (Publ) Present in Europe in other categories | – | OTS Hip Solution Pinnacle OTS Hip Guide Reusable Set Pinnacle OTS Hip Plan Tracer Set OTS Hip Guide SW Attachment Adapter Twin OT | registered |
| 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) |
| Spineology, Inc. | United States | Navigation OptiMesh Navigation Instruments Spineology Navigation Instruments | K251943 (2025) |
| BIOMET SPINE LLC | – | Vital™ Navigation System Vital™ | registered |
| CLARIANCE | France | ERISMA® LP_NAVIGATED INSTRUMENTS Erisma®-LP Navigated | K202956 (2021) |
| 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 |
| Joimax GmbH Present in Europe in other categories | Germany | Intracs® Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mm Joimax® Intracs® EM Patient Mapper - LAT Joimax® Intracs® EM Sensor Wire 180 Joimax® Intracs® EM Y-Adapter K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mm | K192663 (2020) |
| ORTHOKEY ITALIA SRL Present in Europe in other categories | Italy | Perseus | K192653 (2020) |
| Depuy, Inc. | United States | VELYS CUPTIMIZE Advanced VELYS PURESIGHT | registered |
| Medyssey Co., Ltd. | South Korea | Medyssey Navigation Instrument | K242806 (2025) |
| DEGEN MEDICAL, INC. | United States | DeGen Navigated Instrumentation | K213918 (2022) |
| PROMETHEAN RESTORATIVE LLC | United States | DYNAMIS™ Navigation System | K252962 (2026) |
| 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) |
| Fiagon GmbH Present in Europe in other categories | Germany | RIWOtrack Cube4D Adapter for Flexsensor Navigation Sensor Flexarm RIWOtrack Clipsensor Localizer K-Wire Adapter for Clipsensor | K230700 (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) |
| Medtech S.A Present in Europe in other categories | France | ROBOT ROSA ONE (USA) STERILE ROBOT ARM INTERFACE (V3) ROSA ONE BRAIN APPLICATION (US) ROSA ONE SURGICAL ASSISTANT (US) | K192173 (2019) |
| Novarad Corporation Present in Europe in other categories | United States | VisAR | K220146 (2022) |
| DEPUY SPINE, LLC | United States | TRIALTIS Spine System CROSSNAV | registered |
| Augmedics, Ltd. | Israel | 8” Tablet 8” Tablet Docking Perc Pin Adaptor | registered |
| 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) |
| 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 |
| Providence Medical Technology, Inc. | United States | CORUS NAVIGATION ACCESS SYSTEM-GLX CORUS Navigation Access System | K261665 (2026) |
| Comerge AG Present in Europe in other categories | Switzerland | Neo ADVISE | K230195 (2024) |
| NVIEW MEDICAL INC. | United States | nView s1 with nav option | registered |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | ClarifEye | registered |
| Surgical Theater, Inc. | United States | SpineAR SNAP | registered |
| Taiwan Main Orthopaedic Biotechnology Co., Ltd. Present in Europe in other categories | Taiwan | Disposable Passive Sphere | registered |
| 3D Instrumentation Sdn Bhd | Malaysia | – | registered |
| 3D Medical Manufacturing, inc. DBA Tecomet | United States | – | registered |
| A7 integration | Canada | – | registered |
| ALPHATEC HOLDINGS, INC. | United States | – | registered |
| ARCH - Quakertown | United States | – | registered |
| ARCH Medical Solutions - Olive Branch | United States | – | registered |
| ARCH Medical Solutions - Seabrook | United States | – | registered |
| ATL Technology LLC | United States | – | registered |
| Aesculap Implant Systems, LLC | United States | – | K153700 (2016) |
| Alden Tool Company, Inc. | United States | – | registered |
| All Quality & Services, Inc. | United States | – | registered |
| Alpha Manufacturing & Design, LLC. | United States | – | registered |
| Altus Partners, LLC | United States | – | K243419 (2025) |
| American Manufacturing and Engineering | United States | – | registered |
| Apex (Guangzhou) Tools & Orthopedics Co. | China | – | registered |
| Arch Medical Solutions | United States | – | registered |
| Arch Medical Solutions - Philadelphia, LLC DBA JADE PRECISIO | United States | – | registered |
| Armbruster GmbH | Germany | – | registered |
| Arvato Netherlands B.V. | Netherlands | – | registered |
| Autocam Medical | United States | – | registered |
| Avalign Delivery Systems Division | United States | – | registered |
| Avalign Instruments & Implants | United States | – | registered |
| Avalign Technologies, Inc. | United States | – | registered |
| Axial Medical | United States | – | registered |
| B&G Manufacturing Company | United States | – | registered |
| B&J Medical | United States | – | registered |
The 100 most active manufacturers are shown, out of 298.
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