OLO
- Product code
- OLO
- Device name
- Orthopedic Stereotaxic Instrument
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4560
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 133
- Summaries archived here
- 120 (direct download)
- 510(k) clearances (all years, FDA)
- 440 (all years; only the last 3 years are listed here)
FDA classification definition
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
510(k) clearances, last 3 years (133)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262506 | 2026-08-20 | Remex Medical Corp. | Remex Spine Surgery Navigation - Universal Instrumen… | FDA |
| K261410 | 2026-07-30 | Suite 201, National Innovation Centre | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), … | |
| K261205 | 2026-07-29 | Spineart SA | SPINEART Navigation Instrument System | |
| K261024 | 2026-07-24 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K262121 | 2026-07-24 | SurGenTec, LLC | Ion-L Navigated Instruments | FDA |
| K261113 | 2026-07-22 | Ecential Robotics | Op.n Spine Navigation and Robotic Guidance | |
| K261852 | 2026-07-01 | Ortoma AB | OTS Hip | |
| K253921 | 2026-06-26 | Silony Medical GmbH | VERTICALE® Navigation Instruments | |
| K260480 | 2026-06-25 | Depuy Ireland UC | VELYS Robotic-Assisted Solution | |
| K260369 | 2026-06-20 | LEM Surgical AG | Dynamis Robotic Surgical System | |
| K261665 | 2026-06-18 | Providence Medical Technology, Inc. | CORUS Navigation System-GN | |
| K260571 | 2026-06-02 | Life Spine, Inc. | SIMPACT Sacroiliac Joint Fixation System GX Navigati… | |
| K261060 | 2026-05-29 | Tyber Medical, LLC | Navigated LLIF Impactable Tracker | |
| K254157 | 2026-05-26 | Medos International SARL | CROSSNAV Navigation Enabled Instruments for Disc Pre… | |
| K260329 | 2026-05-22 | SurGenTec, LLC | Ion-C Navigation Instruments | |
| K260582 | 2026-05-21 | Orthosoft Inc. (d/b/a) Zimmer CAS | ROSA® Shoulder System | |
| K252880 | 2026-05-11 | Pytheas Navigation Sas | Pytheas Your Guided Trajectory | |
| K260011 | 2026-04-16 | Foundation Surgical Group, Inc. | Foundation Surgical Navigated Lateral Disc Prep Inst… | |
| K254158 | 2026-04-09 | Spineart SA | SPINEART Navigation Instrument System | |
| K260240 | 2026-03-27 | Medos International SARL | SYMPHONY Navigation Ready Instruments | |
| K260601 | 2026-03-26 | Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | |
| K252037 | 2026-03-25 | Curexo, Inc. | CUVIS-joint (CJ150) | |
| K253604 | 2026-03-20 | SurGenTec, LLC | TiLink-L Navigation Instruments | |
| K253444 | 2026-03-18 | MiRus, LLC | EUROPA Posterior Cervical Fusion Navigated Instrume… | |
| K260546 | 2026-03-17 | K2m, Inc. | Q Pedicle Instruments | |
| K260010 | 2026-03-03 | THINK Surgical, Inc. | TMINI® Miniature Robotic System | |
| K260222 | 2026-02-25 | Mako Surgical Corp. | Mako Total Knee Application | |
| K252989 | 2026-02-20 | Point Robotics MedTech, Inc. | POINT Kinguide Agile Hybrid Navigation System; DRF… | |
| K253623 | 2026-02-19 | Stryker Leibinger GmbH & Co KG | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgr… | |
| K254148 | 2026-02-19 | Silony Medical GmbH | VERTICALE GPS Instruments | |
| K252597 | 2026-02-19 | Alphatec Spine, Inc. | Valence Robotic Navigation System; Valence Robotic N… | |
| K253381 | 2026-02-12 | Medtronic Navigation, Inc. | Stealth AXiS Surgical System with Stealth AXiS Spi… | |
| K252058 | 2026-02-06 | Balmoral Medical, LLC | ROSA Knee System with UltraSound Imaging Platform (U… | |
| K252871 | 2026-02-06 | Stryker Leibinger GmbH & Co KG | Spine Guidance 5.3 Software; Q Interbody Instruments… | |
| K252873 | 2026-02-06 | K2m, Inc. | Q Interbody Instruments | |
| K252087 | 2026-02-03 | Ulrich Medical USA, Inc. | Navigation Module of the Cortium® System | |
| K252755 | 2026-01-23 | Point Robotics MedTech, Inc. | POINT Kinguide Agile Robotic Arm Surgical Stereotact… | |
| K252962 | 2026-01-12 | Promethean Restorative, LLC | DYNAMIS Navigation System | |
| K253661 | 2025-12-22 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K252950 | 2025-12-15 | Proprio, Inc. | Paradigm System | |
| K252841 | 2025-12-05 | Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI XT (CORI XT) | |
| K251943 | 2025-12-04 | Spineology, Inc. | Spineology Navigation Instruments | |
| K251314 | 2025-11-13 | Orthosoft Inc. (d/b/a) Zimmer CAS | Rosa® Knee System | |
| K250599 | 2025-11-05 | Globus Medical, Inc. | ExcelsiusGPS Instruments | FDA |
| K252088 | 2025-10-31 | Orthofix US, LLC | Firebird SI Navigation System | |
| K252742 | 2025-10-28 | Tyber Medical, LLC | Navigated Instruments | |
| K250520 | 2025-10-27 | Osteocentric Technologies, Inc. | OsteoCentric Navigated Instruments System | |
| K251282 | 2025-10-17 | Medtronic Navigation, Inc. | StealthStation S8 Spine Software | |
| K252544 | 2025-10-10 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K251971 | 2025-09-25 | Stryker Instruments | RPS Primary TKA Software; RPS Console; RPS Saw One; … | |
| K251780 | 2025-09-15 | SI-BONE, Inc. | iGPS Navigation Instruments | |
| K252562 | 2025-09-12 | Brainlab AG | Spine & Trauma Navigation Instruments | |
| K251316 | 2025-09-11 | Mazor Robotics , Ltd. | Mazor X System / Mazor X Stealth Edition | |
| K250167 | 2025-08-18 | Evolution Spine | Evolution Spine Navigation Instruments | |
| K251060 | 2025-07-30 | Providence Medical Technology, Inc. | CORUS Navigation System-GX | |
| K251073 | 2025-07-23 | Innovasis, Inc. | Innovasis Navigation Instruments (Vector G-E Navigat… | |
| K250877 | 2025-06-20 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K242933 | 2025-06-18 | Spineart SA | SPINEART Navigation Instrument System | |
| K242464 | 2025-06-05 | Medtronic Navigation, Inc. | Stealth Spine Clamps; ModuLeX Shank Mounts | |
| K250879 | 2025-06-04 | Proprio, Inc. | Paradigm System | |
| K251315 | 2025-05-29 | Remex Medical Corp. | Anatase Spine Surgery Navigation System and Remex Sp… | |
| K250086 | 2025-05-16 | Ortoma AB | OTS Hip | FDA |
| K243419 | 2025-05-08 | Altus Partners, LLC | Altus Spine Navigation System | |
| K250608 | 2025-04-25 | Mako Surgical Corp. | Mako Total Knee Application (3.0); Hybrid Tip Pointe… | |
| K243326 | 2025-04-23 | LEM Surgical AG | Dynamis Robotic Surgical System | |
| K242806 | 2025-04-16 | Medyssey Co, Ltd. | Medyssey Navigation System | FDA |
| K243514 | 2025-04-03 | Spine Wave, Inc. | Salvo® Robotic Navigation Instruments | |
| K243659 | 2025-04-02 | SeaSpine Orthopedics Corporation | FLASH Facet Fusion Instruments, IsoTis® Facet Fusio… | FDA |
| K250182 | 2025-03-24 | Innovasis, Inc. | Innovasis Navigation Instruments | |
| K243958 | 2025-03-21 | Stryker Instruments | Consolidated Operating Room Equipment (CORE) 2 Conso… | |
| K242121 | 2025-03-14 | Monogram Orthopaedics, Inc. | mBôs (Monogram mBôs TKA System) | |
| K242890 | 2025-03-07 | Spineart SA | SPINEART Navigation Instrument System | |
| K242914 | 2025-03-07 | Ecential Robotics | Op.n(TM) Navigation | |
| K243751 | 2025-03-05 | Mako Surgical Corp. | Mako Total Hip Application 5.0 | |
| K243258 | 2025-02-21 | Proprio, Inc. | Paradigm System | |
| K243387 | 2025-01-29 | Gyder Surgical Pty, Ltd. | GYDER® Hip System | |
| K243814 | 2025-01-10 | Globus Medical, Inc. | NuVasive Pulse System | |
| K243481 | 2025-01-06 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K243671 | 2024-12-20 | Globus Medical, Inc. | ExcelsiusGPS® Instruments | |
| K243560 | 2024-12-13 | Remex Medical Corp. | Remex Spine Surgery Navigation Instrument | |
| K243073 | 2024-12-06 | GS Medical Co., Ltd. | AnyPlus Navigated Instruments System | |
| K243285 | 2024-11-15 | THINK Surgical, Inc. | TMINI Miniature Robotic System | FDA |
| K242373 | 2024-11-07 | Mako Surgical Corp. | Mako Shoulder Application (1.0) | |
| K242864 | 2024-10-18 | Orthosoft Inc. (d/b/a) Zimmer CAS | ROSA® Knee System | |
| K240160 | 2024-10-17 | Astura Medical | EGPS Navigated Instruments | |
| K241893 | 2024-09-16 | Medos International SARL | CROSSNAV Navigation Enabled Instruments and UNAS Nav… | |
| K241517 | 2024-08-27 | Stryker Leibinger GmbH & Co KG | Q Guidance System; Mako Spine System; | |
| K242264 | 2024-08-23 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K242009 | 2024-08-08 | Kico Knee Innovation Company Pty, Ltd. | 360CAS Knee | |
| K241644 | 2024-08-07 | Spineart SA | SPINEART Navigation Instrument System | |
| K233706 | 2024-08-02 | Nuvasive | Bendini Cloud Application | FDA |
| K233725 | 2024-07-26 | Medivis, Inc. | Spine Navigation System | |
| K241171 | 2024-07-25 | Stryker Leibinger GmbH & Co KG | Spine Guidance Software (Version 5.1); Consolidated … | |
| K241130 | 2024-07-24 | Point Robotics MedTech, Inc. | POINT Kinguide Agile Hybrid Navigation System (PSH… | |
| K241031 | 2024-07-12 | THINK Surgical, Inc. | TMINI Miniature Robotic System (TMINI 1.1) | |
| K241625 | 2024-07-05 | Remex Medical Corp. | Anatase Navi Disposable Instrument | |
| K233255 | 2024-06-17 | DePuy Synthes | CROSSNAV Navigation Enabled Instruments | |
| K233256 | 2024-06-17 | DePuy Synthes | Robotic Integration Instruments | FDA |
| K240721 | 2024-06-14 | Globus Medical, Inc. | ExcelsiusFlex | |
| K241082 | 2024-06-14 | Innosys Co., Ltd. | INNOVERSE Navigation Instruments | |
| K233254 | 2024-06-14 | DePuy Synthes | TELIGEN System Navigation Ready Instruments | |
| K233228 | 2024-06-14 | Ecential Robotics | Spine Navigation and Robotic-Assistance Device | |
| K241011 | 2024-06-11 | Mako Surgical Corp. | Mako Total Knee Application | FDA |
| K240662 | 2024-06-06 | Stryker Leibinger GmbH & Co KG | Spine Guidance Software (version 5.0); Xia 3/ Serrat… | |
| K240951 | 2024-06-06 | Alphatec Spine | Invictus Robotic Navigation Instruments | |
| K240211 | 2024-06-05 | Depuy Ireland UC | VELYS Robotic-Assisted Solution | |
| K240701 | 2024-05-23 | Brainlab AG | Drill Guide; Drill Bit; Spine & Trauma Navigation | |
| K240625 | 2024-05-03 | Providence Medical Technology, Inc. | CORUS Navigation Access System | |
| K233513 | 2024-05-01 | Remex Medical Corp. | Remex Spine Surgery Navigation System II | |
| K240062 | 2024-04-29 | Insight Medical Systems, Inc. | ARVIS® Shoulder | |
| K240568 | 2024-04-29 | Globus Medical, Inc. | DuraPro Oscillating System | FDA |
| K240647 | 2024-04-05 | Zimvie Spine (Zimmer Biomet Spine, Inc… | Virage® Navigation System | FDA |
| K233595 | 2024-03-29 | Genesys Spine | Genesys Spine Sacroiliac Joint Fusion System with Na… | |
| K234047 | 2024-03-20 | Brainlab AG | Automatic Registration | |
| K240139 | 2024-03-18 | Blue Belt Technologies, Inc. | Real Intelligence CORI | |
| K233542 | 2024-03-14 | Stryker Leibinger GmbH & Co KG | Ortho Guidance Precision Knee Software; Ortho Guidan… | |
| K232140 | 2024-03-11 | Ortoma AB | OTS Hip | |
| K230195 | 2024-03-08 | Comerge AG | Neo ADVISE software | |
| K232800 | 2024-02-23 | SI-BONE, Inc. | Navigation Tracking Instruments | |
| K233199 | 2024-02-21 | Orthosoft Inc (D/B/A Zimmer Cas) | ROSA® Shoulder System | |
| K233638 | 2024-02-09 | Globus Medical, Inc. | VERZA High Speed Drills | |
| K233299 | 2024-01-26 | Blue Ortho | ExactechGPS® System | |
| K233227 | 2023-12-14 | Depuy Ireland UC | VELYS Robotic-Assisted Solution | |
| K232572 | 2023-12-13 | Kalitec Direct, LLC Doing Business AS … | Kalitec Navigated Instrument System | |
| K230700 | 2023-11-20 | Fiagon GmbH | RIWOtrack Navigation System | |
| K233443 | 2023-11-16 | Zimvie Spine (Zimmer Biomet Spine, Inc… | Vital Navigation System | |
| K232533 | 2023-11-16 | Orthosoft D/B/A Zimmer Cas | ROSA Partial Knee System | |
| K232521 | 2023-11-16 | Blue Ortho | ExactechGPS® Total Ankle Application | |
| K232345 | 2023-11-02 | Alphatec Spine, Inc. | ATEC Posterior Navigated Disc Prep Instruments | |
| K231494 | 2023-10-27 | Corelink, LLC | CoreLink Robotic Navigation Instruments | FDA |
| K232802 | 2023-10-12 | THINK Surgical, Inc. | TMINI Miniature Robotic System | |
| K232044 | 2023-10-06 | Alphatec Spine, Inc. | Invictus Robotic Navigation Instruments | |
| K231527 | 2023-09-29 | Medos International Sàrl | TriALTIS Navigation Enabled Instruments |
Official FDA classification page: OLO
Classification and pathway per current FDA publications. Data from openFDA (CC0).