{
  "code": "OLO",
  "deviceName": "Orthopedic Stereotaxic Instrument",
  "deviceClass": "II",
  "regulationNumber": "882.4560",
  "panel": "Neurology",
  "definition": "Stereotaxic guidance during orthopedic surgery procedures.  Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 437,
    "last12Months": 51
  },
  "adverseEvents": {
    "total": 7128,
    "last12Months": 1908
  },
  "reviewDays": {
    "median": 97,
    "sampleSize": 437
  },
  "recalls": {
    "total": 112,
    "recent": [
      {
        "resNumber": "Z-2716-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Think Surgical, Inc.",
        "firmAsPublished": "Think Surgical, Inc.",
        "reason": "Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.",
        "initiated": "2026-05-08"
      },
      {
        "resNumber": "Z-2292-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Kico Knee Innovation Company",
        "firmAsPublished": "Kico Knee Innovation Company",
        "reason": "The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.",
        "initiated": "2026-04-23"
      },
      {
        "resNumber": "Z-2293-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Kico Knee Innovation Company",
        "firmAsPublished": "Kico Knee Innovation Company",
        "reason": "The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.",
        "initiated": "2026-04-23"
      },
      {
        "resNumber": "Z-1629-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Orthalign, Inc",
        "firmAsPublished": "Orthalign, Inc",
        "reason": "Drill plates manufactured out of specification can result in a bone cut in excess 00800\"(2.8448mm)",
        "initiated": "2026-02-10"
      },
      {
        "resNumber": "Z-1630-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Orthalign, Inc",
        "firmAsPublished": "Orthalign, Inc",
        "reason": "Drill plates manufactured out of specification can result in a bone cut in excess 00800\"(2.8448mm)",
        "initiated": "2026-02-10"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K262121",
      "deviceName": "Ion-L Navigated Instruments",
      "applicant": "SurGenTec, LLC",
      "company": "SurGenTec, LLC",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-06-23"
    },
    {
      "kNumber": "K261024",
      "deviceName": "TMINI Miniature Robotic System",
      "applicant": "THINK Surgical, Inc.",
      "company": "Think Surgical, Inc.",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-03-30"
    },
    {
      "kNumber": "K261113",
      "deviceName": "Op.n™ Spine Navigation and Robotic Guidance",
      "applicant": "Ecential Robotics",
      "company": "Ecential Robotics",
      "decisionDate": "2026-07-22",
      "dateReceived": "2026-04-03"
    },
    {
      "kNumber": "K261852",
      "deviceName": "OTS Hip",
      "applicant": "Ortoma AB",
      "company": "ORTOMA AB",
      "decisionDate": "2026-07-01",
      "dateReceived": "2026-06-03"
    },
    {
      "kNumber": "K253921",
      "deviceName": "VERTICALE® Navigation Instruments",
      "applicant": "Silony Medical GmbH",
      "company": "Silony Medical GmbH",
      "decisionDate": "2026-06-26",
      "dateReceived": "2025-12-08"
    },
    {
      "kNumber": "K260480",
      "deviceName": "VELYS™ Robotic-Assisted Solution",
      "applicant": "Depuy Ireland UC",
      "company": "Depuy Ireland UC",
      "decisionDate": "2026-06-25",
      "dateReceived": "2026-02-13"
    },
    {
      "kNumber": "K260369",
      "deviceName": "Dynamis Robotic Surgical System",
      "applicant": "LEM Surgical AG",
      "company": "LEM Surgical AG",
      "decisionDate": "2026-06-20",
      "dateReceived": "2026-02-05"
    },
    {
      "kNumber": "K261665",
      "deviceName": "CORUS™ Navigation System-GN",
      "applicant": "Providence Medical Technology, Inc.",
      "company": "Providence Medical Technology, Inc.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2026-05-20"
    },
    {
      "kNumber": "K260571",
      "deviceName": "SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments",
      "applicant": "Life Spine, Inc.",
      "company": "Life Spine, Inc.",
      "decisionDate": "2026-06-02",
      "dateReceived": "2026-02-19"
    },
    {
      "kNumber": "K261060",
      "deviceName": "Navigated LLIF Impactable Tracker",
      "applicant": "Tyber Medical, LLC",
      "company": "Tyber Medical",
      "decisionDate": "2026-05-29",
      "dateReceived": "2026-03-31"
    }
  ],
  "topApplicants": [
    {
      "name": "Brainlab AG",
      "count": 21
    },
    {
      "name": "Mako Surgical Corp.",
      "count": 19
    },
    {
      "name": "THINK Surgical, Inc.",
      "count": 19
    },
    {
      "name": "Blue Belt Technologies, Inc.",
      "count": 18
    },
    {
      "name": "Medtronic Sofamor Danek USA, Inc.",
      "count": 15
    }
  ],
  "topCompanies": [
    {
      "name": "Mako Surgical Corporation",
      "count": 23,
      "spellings": 2
    },
    {
      "name": "Brainlab AG",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Think Surgical, Inc.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Blue Belt Technologies, Inc.",
      "count": 18,
      "spellings": 1
    },
    {
      "name": "Medtronic Sofamor Danek USA, Inc",
      "count": 15,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Pytheas Navigation Sas",
      "since": "2026-05-11",
      "kNumber": "K252880"
    },
    {
      "name": "Foundation Surgical Group, Inc.",
      "since": "2026-04-16",
      "kNumber": "K260011"
    },
    {
      "name": "SurGenTec, LLC",
      "since": "2026-03-20",
      "kNumber": "K253604"
    },
    {
      "name": "Balmoral Medical, LLC",
      "since": "2026-02-06",
      "kNumber": "K252058"
    },
    {
      "name": "Promethean Restorative Inc.",
      "since": "2026-01-12",
      "kNumber": "K252962"
    },
    {
      "name": "Orthofix US, LLC",
      "since": "2025-10-31",
      "kNumber": "K252088"
    },
    {
      "name": "Tyber Medical",
      "since": "2025-10-28",
      "kNumber": "K252742"
    },
    {
      "name": "Osteocentric Technologies D.B.A. Osteocentric Trauma",
      "since": "2025-10-27",
      "kNumber": "K250520"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 73,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 96,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 140,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 63,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 86,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 85,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 77,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 76,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 118,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 136,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 196,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 220,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 159,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 159,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 129,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 175,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 218,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 222,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 247,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 213,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 280,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 515,
        "expectedLow": 134.3981849289349,
        "expectedHigh": 283.36509448390626,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 297,
        "expectedLow": 88.659417934519,
        "expectedHigh": 436.6654172552857,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 209,
        "expectedLow": 99.68834941103309,
        "expectedHigh": 511.9901323602717,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 238,
        "expectedLow": 72.02325589891836,
        "expectedHigh": 498.4253861819879,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 192,
        "expectedLow": 57.880517236766394,
        "expectedHigh": 450.20550504019735,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 263,
        "expectedLow": 46.164629532172405,
        "expectedHigh": 441.61534567971,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 206,
        "expectedLow": 97.63494801327602,
        "expectedHigh": 688.1198222575299,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 260,
        "expectedLow": 27.52847669715668,
        "expectedHigh": 482.856735305568,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 224,
        "expectedLow": 33.49298356814732,
        "expectedHigh": 507.05677317053716,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 232,
        "expectedLow": 16.68138763620238,
        "expectedHigh": 492.98276728759015,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 217,
        "expectedLow": 6.578464415283124,
        "expectedHigh": 439.9102749815414,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 341,
        "expectedLow": 6.2034700277821,
        "expectedHigh": 486.21450703953144,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 257,
        "expectedLow": 43.719368138272834,
        "expectedHigh": 600.3334792922972,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 243,
        "expectedLow": 123.63576697052979,
        "expectedHigh": 382.4661357771303,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 218,
        "expectedLow": 169.14478648456748,
        "expectedHigh": 374.53046915273745,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "OLO (Orthopedic Stereotaxic Instrument) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2716-2026, Z-2292-2026, Z-2293-2026, Z-1629-2026, Z-1630-2026). 9 first-time filers in the last 12 months, including Pytheas Navigation Sas and Foundation Surgical Group, Inc (K252880, K260011, K253604, K252058, K252962). The code is crowded, scoring 95 of 100 — 127 companies hold a clearance here and 51 arrived in the last 12 months (OLO:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2716-2026",
          "Z-2292-2026",
          "Z-2293-2026",
          "Z-1629-2026",
          "Z-1630-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "9 first-time filers in the last 12 months, including Pytheas Navigation Sas and Foundation Surgical Group, Inc.",
        "recordIds": [
          "K252880",
          "K260011",
          "K253604",
          "K252058",
          "K252962"
        ],
        "severity": 49
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 95 of 100 — 127 companies hold a clearance here and 51 arrived in the last 12 months",
        "recordIds": [
          "OLO:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AOLO"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AOLO"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AOLO"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AOLO"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AOLO"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AOLO"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AOLO"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.750Z"
}