Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OLO — Predicate Candidate Screening
439 FDA 510(k) clearances under this product code; the 50 most recent screened below.
97 daysmedian FDA review time
247 days90th percentile
439clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001- | Suite 201, National Innovation Centre | 2026-07-30 | 91 | 0 |
| K261205 | SPINEART Navigation Instrument System | Spineart SA | 2026-07-29 | 107 | 0 |
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2026-07-24 | 116 | 0 |
| K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | 2026-07-24 | 31 | 0 |
| K261113 | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | 2026-07-22 | 110 | 0 |
| K261852 | OTS Hip | Ortoma AB | 2026-07-01 | 28 | 0 |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | 2026-06-26 | 200 | 0 |
| K260480 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2026-06-25 | 132 | 0 |
| K260369 | Dynamis Robotic Surgical System | LEM Surgical AG | 2026-06-20 | 135 | 0 |
| K261665 | CORUS™ Navigation System-GN | Providence Medical Technology, Inc. | 2026-06-18 | 29 | 0 |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instr | Life Spine, Inc. | 2026-06-02 | 103 | 0 |
| K261060 | Navigated LLIF Impactable Tracker | Tyber Medical, LLC | 2026-05-29 | 59 | 0 |
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation | Medos International SARL | 2026-05-26 | 155 | 0 |
| K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | 2026-05-22 | 112 | 0 |
| K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-05-21 | 90 | 0 |
| K252880 | Pytheas Your Guided Trajectory | Pytheas Navigation Sas | 2026-05-11 | 243 | 0 |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | 2026-04-16 | 104 | 0 |
| K254158 | SPINEART Navigation Instrument System | Spineart SA | 2026-04-09 | 108 | 0 |
| K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | 2026-03-27 | 60 | 0 |
| K260601 | REAL INTELLIGENCE™ CORI™ | Blue Belt Technologies, Inc. | 2026-03-26 | 30 | 0 |
| K252037 | CUVIS-joint (CJ150) | Curexo, Inc. | 2026-03-25 | 268 | 0 |
| K253604 | TiLink-L Navigation Instruments | SurGenTec, LLC | 2026-03-20 | 122 | 0 |
| K253444 | EUROPA™ Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | 2026-03-18 | 167 | 0 |
| K260546 | Q Pedicle Instruments | K2m, Inc. | 2026-03-17 | 27 | 0 |
| K260010 | TMINI® Miniature Robotic System | THINK Surgical, Inc. | 2026-03-03 | 60 | 1 |
| K260222 | Mako Total Knee Application | Mako Surgical Corp. | 2026-02-25 | 30 | 0 |
| K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accesso | Point Robotics MedTech, Inc. | 2026-02-20 | 155 | 0 |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigatio | Alphatec Spine, Inc. | 2026-02-19 | 188 | 0 |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spi | Stryker Leibinger GmbH & Co KG | 2026-02-19 | 93 | 0 |
| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | 2026-02-19 | 59 | 0 |
| K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clini | Medtronic Navigation, Inc. | 2026-02-12 | 135 | 0 |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite | Stryker Leibinger GmbH & Co KG | 2026-02-06 | 149 | 0 |
| K252873 | Q Interbody Instruments | K2m, Inc. | 2026-02-06 | 149 | 0 |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | 2026-02-06 | 220 | 0 |
| K252087 | Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. | 2026-02-03 | 216 | 0 |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic Syste | Point Robotics MedTech, Inc. | 2026-01-23 | 147 | 0 |
| K252962 | DYNAMIS™ Navigation System | Promethean Restorative, LLC | 2026-01-12 | 118 | 0 |
| K253661 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-12-22 | 32 | 0 |
| K252950 | Paradigm System | Proprio, Inc. | 2025-12-15 | 90 | 0 |
| K252841 | REAL INTELLIGENCE™ CORI™ XT (CORI XT) | Blue Belt Technologies, Inc. | 2025-12-05 | 88 | 0 |
| K251943 | Spineology Navigation Instruments | Spineology, Inc. | 2025-12-04 | 163 | 0 |
| K251314 | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2025-11-13 | 199 | 0 |
| K250599 | ExcelsiusGPS™ Instruments | Globus Medical, Inc. | 2025-11-05 | 250 | 0 |
| K252088 | Firebird SI Navigation System | Orthofix US, LLC | 2025-10-31 | 121 | 0 |
| K252742 | Navigated Instruments | Tyber Medical, LLC | 2025-10-28 | 61 | 0 |
| K250520 | OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. | 2025-10-27 | 248 | 0 |
| K251282 | StealthStation S8 Spine Software | Medtronic Navigation, Inc. | 2025-10-17 | 176 | 0 |
| K252544 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025-10-10 | 59 | 0 |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cabl | Stryker Instruments | 2025-09-25 | 91 | 0 |
| K251780 | iGPS Navigation Instruments | SI-BONE, Inc. | 2025-09-15 | 97 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda