{
  "code": "HAW",
  "deviceName": "Neurological Stereotaxic Instrument",
  "deviceClass": "II",
  "regulationNumber": "882.4560",
  "panel": "Neurology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 423,
    "last12Months": 5
  },
  "adverseEvents": {
    "total": 9295,
    "last12Months": 1358
  },
  "reviewDays": {
    "median": 115,
    "sampleSize": 423
  },
  "recalls": {
    "total": 197,
    "recent": [
      {
        "resNumber": "Z-2006-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Elekta Limited",
        "firmAsPublished": "Elekta, Inc.",
        "reason": "Locking mechanisms  may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.",
        "initiated": "2026-03-19"
      },
      {
        "resNumber": "Z-0963-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Howmedica Osteonics Corp.",
        "firmAsPublished": "Howmedica Osteonics Corp.",
        "reason": "When the device is activated during surgery, the device software issues an error message \"Instrument Face Mask (6001385000000) is not valid for this application\" resulting in an inability to use the device.",
        "initiated": "2025-11-12"
      },
      {
        "resNumber": "Z-0433-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Elekta Limited",
        "firmAsPublished": "Elekta, Inc.",
        "reason": "Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound",
        "initiated": "2025-09-30"
      },
      {
        "resNumber": "Z-0312-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "FHC, Inc.",
        "firmAsPublished": "FHC, Inc.",
        "reason": "A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.",
        "initiated": "2024-10-04"
      },
      {
        "resNumber": "Z-0227-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Elekta Instrument AB",
        "firmAsPublished": "Elekta Instrument AB",
        "reason": "Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.",
        "initiated": "2024-09-25"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253663",
      "deviceName": "Zeta Navigation System",
      "applicant": "Zeta Surgical, Inc.",
      "company": "Zeta Surgical, Inc.",
      "decisionDate": "2026-05-01",
      "dateReceived": "2025-11-20"
    },
    {
      "kNumber": "K253379",
      "deviceName": "Stealth AXiS Cranial clinical application",
      "applicant": "Medtronic Navigation, Inc.",
      "company": "Medtronic Navigation, Inc.",
      "decisionDate": "2026-03-26",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K231897",
      "deviceName": "NeuroAlign software",
      "applicant": "Medivis, Inc.",
      "company": "Medivis, Inc.",
      "decisionDate": "2025-10-21",
      "dateReceived": "2023-06-28"
    },
    {
      "kNumber": "K251317",
      "deviceName": "SOLOPASS 2.0 System",
      "applicant": "Intravent Medical Partners",
      "company": "Intravent Medical Partners, LP",
      "decisionDate": "2025-09-05",
      "dateReceived": "2025-04-29"
    },
    {
      "kNumber": "K250893",
      "deviceName": "Ball Joint Guide Array (66295)",
      "applicant": "Bayer Medical Care, Inc.",
      "company": "Bayer Medical Care, Inc.",
      "decisionDate": "2025-09-04",
      "dateReceived": "2025-03-25"
    },
    {
      "kNumber": "K250505",
      "deviceName": "EZ-FIDUCIALS",
      "applicant": "Phasor Health, LLC",
      "company": "Phasor Health, LLC",
      "decisionDate": "2025-07-09",
      "dateReceived": "2025-02-21"
    },
    {
      "kNumber": "K242575",
      "deviceName": "Stereotaxic Guiding Surgical Devices, NaoTrac S",
      "applicant": "Brain Navi Biotechnology Co., Ltd.",
      "company": "Brain Navi Biotechnology Co., Ltd.",
      "decisionDate": "2025-05-23",
      "dateReceived": "2024-08-29"
    },
    {
      "kNumber": "K241327",
      "deviceName": "Navient Image Guide Navigation System (955-NC-NC), Cranial",
      "applicant": "Claronav",
      "company": "Claronav, Inc.",
      "decisionDate": "2025-02-05",
      "dateReceived": "2024-05-10"
    },
    {
      "kNumber": "K243698",
      "deviceName": "Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT",
      "applicant": "Brainlab AG",
      "company": "Brainlab AG",
      "decisionDate": "2025-01-28",
      "dateReceived": "2024-11-29"
    },
    {
      "kNumber": "K243657",
      "deviceName": "ClearPoint System (Software Version 3.0)",
      "applicant": "ClearPoint Neuro, Inc.",
      "company": "ClearPoint Neuro, Inc.",
      "decisionDate": "2025-01-24",
      "dateReceived": "2024-11-27"
    }
  ],
  "topApplicants": [
    {
      "name": "Brainlab AG",
      "count": 57
    },
    {
      "name": "Medtronic Navigation, Inc.",
      "count": 18
    },
    {
      "name": "Elekta Instrument AB",
      "count": 16
    },
    {
      "name": "Image-Guided Neurologics, Inc.",
      "count": 15
    },
    {
      "name": "Surgical Navigation Technologies, Inc.",
      "count": 15
    }
  ],
  "topCompanies": [
    {
      "name": "Brainlab AG",
      "count": 59,
      "spellings": 3
    },
    {
      "name": "Medtronic Navigation, Inc.",
      "count": 19,
      "spellings": 2
    },
    {
      "name": "Elekta Instrument AB",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Image-Guided Neurologics, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Surgical Navigation Technologies, Inc.",
      "count": 15,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Medivis, Inc.",
      "since": "2025-10-21",
      "kNumber": "K231897"
    },
    {
      "name": "Bayer Medical Care, Inc.",
      "since": "2025-09-04",
      "kNumber": "K250893"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 131,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 160,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 188,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 174,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 203,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 211,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 196,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 226,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 176,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 371,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 260,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 253,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 203,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 223,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 175,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 281,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 504,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 392,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 445,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 337,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 311,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 305,
        "expectedLow": 152.2264055938906,
        "expectedHigh": 477.7482532424069,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 498,
        "expectedLow": 133.2223731483778,
        "expectedHigh": 407.78380974502903,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 302,
        "expectedLow": 159.25403562228294,
        "expectedHigh": 598.854794965727,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 296,
        "expectedLow": 142.88352728139668,
        "expectedHigh": 591.495299105835,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 297,
        "expectedLow": 123.72723395461564,
        "expectedHigh": 525.0129348086675,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 381,
        "expectedLow": 131.8014573065678,
        "expectedHigh": 523.0476777131922,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 264,
        "expectedLow": 267.79532081962554,
        "expectedHigh": 815.0696481170988,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 202,
        "expectedLow": 119.1664353557557,
        "expectedHigh": 579.8772297188704,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 208,
        "expectedLow": 63.50027465877946,
        "expectedHigh": 576.1527096246292,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 220,
        "expectedLow": 11.436239460926936,
        "expectedHigh": 558.0342313442997,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 182,
        "expectedLow": 0,
        "expectedHigh": 489.811841235953,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 158,
        "expectedLow": 0,
        "expectedHigh": 535.7228349263664,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 163,
        "expectedLow": 0,
        "expectedHigh": 609.0862917855785,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 129,
        "expectedLow": 0,
        "expectedHigh": 511.27366668612575,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 160,
        "expectedLow": 0,
        "expectedHigh": 426.25705009590087,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "HAW (Neurological Stereotaxic Instrument) has three findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2006-2026, Z-0963-2026, Z-0433-2026). 2 first-time filers in the last 12 months, Medivis, Inc. and Bayer Medical Care, Inc (K231897, K250893). The code is crowded, scoring 80 of 100 — 140 companies hold a clearance here and 5 arrived in the last 12 months (HAW:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2006-2026",
          "Z-0963-2026",
          "Z-0433-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Medivis, Inc. and Bayer Medical Care, Inc.",
        "recordIds": [
          "K231897",
          "K250893"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 80 of 100 — 140 companies hold a clearance here and 5 arrived in the last 12 months",
        "recordIds": [
          "HAW: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%3AHAW"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHAW"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHAW"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHAW"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHAW"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHAW"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHAW"
    }
  ],
  "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": "2026-08-11T13:51:45.706Z"
}