{
  "code": "MNI",
  "deviceName": "Orthosis, Spinal Pedicle Fixation",
  "deviceClass": "II",
  "regulationNumber": "888.3070",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 303,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 302,
    "last12Months": 36
  },
  "reviewDays": {
    "median": 73,
    "sampleSize": 303
  },
  "recalls": {
    "total": 213,
    "recent": [
      {
        "resNumber": "Z-1773-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Xtant Medical Holdings, Inc.",
        "firmAsPublished": "XTANT Medical Holdings, Inc",
        "reason": "Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.",
        "initiated": "2026-02-18"
      },
      {
        "resNumber": "Z-2458-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medicrea International",
        "firmAsPublished": "Medicrea International",
        "reason": "There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.",
        "initiated": "2023-07-12"
      },
      {
        "resNumber": "Z-1030-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "CTL Medical Corporation",
        "firmAsPublished": "CTL Medical Corporation",
        "reason": "the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening.  if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct.  this can lead to failure of the set crew and relies of the rod from the construct.",
        "initiated": "2018-07-05"
      },
      {
        "resNumber": "Z-2873-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Valorem Surgical LLC",
        "firmAsPublished": "Valorem Surgical LLC",
        "reason": "Devices are not consistent with Quality System Requirements.",
        "initiated": "2017-06-21"
      },
      {
        "resNumber": "Z-2874-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Valorem Surgical LLC",
        "firmAsPublished": "Valorem Surgical LLC",
        "reason": "Devices are not consistent with Quality System Requirements.",
        "initiated": "2017-06-21"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K171497",
      "deviceName": "Mikron Spinal Fixation System",
      "applicant": "Mikron Makina Sanayi Ticaret Co. , Ltd.",
      "company": "Mikron Makina Sanayi Ticaret Co. , Ltd.",
      "decisionDate": "2017-10-12",
      "dateReceived": "2017-05-22"
    },
    {
      "kNumber": "K160731",
      "deviceName": "LumFix Spinal Fixation Sytem",
      "applicant": "CG Bio Co., Ltd.",
      "company": "CG Bio Co., Ltd.",
      "decisionDate": "2016-10-04",
      "dateReceived": "2016-03-17"
    },
    {
      "kNumber": "K151458",
      "deviceName": "Double Medical Universal Spine System",
      "applicant": "Double Medical Technology, Inc.",
      "company": "Double Medical Technology, Inc.",
      "decisionDate": "2016-08-22",
      "dateReceived": "2015-06-01"
    },
    {
      "kNumber": "K153273",
      "deviceName": "MySpine Pedicle Screw Placement Guides - LP",
      "applicant": "Medacta International S.A.",
      "company": "Medacta International S.A.",
      "decisionDate": "2016-06-29",
      "dateReceived": "2015-11-12"
    },
    {
      "kNumber": "K160124",
      "deviceName": "LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System",
      "applicant": "Spinevision S.A.",
      "company": "Spinevision S.A.",
      "decisionDate": "2016-04-04",
      "dateReceived": "2016-01-20"
    },
    {
      "kNumber": "K160320",
      "deviceName": "Premier",
      "applicant": "Shandong Weigao Orthopaedic Device Co., Ltd.",
      "company": "Shandong Weigao Orthopaedic Device Co., Ltd.",
      "decisionDate": "2016-04-01",
      "dateReceived": "2016-02-05"
    },
    {
      "kNumber": "K160003",
      "deviceName": "Sniper (R) Spine System",
      "applicant": "Spine Wave, Inc.",
      "company": "Spine Wave, Inc.",
      "decisionDate": "2016-02-26",
      "dateReceived": "2016-01-04"
    },
    {
      "kNumber": "K152324",
      "deviceName": "YAHUA Spinal System",
      "applicant": "Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.",
      "company": "Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.",
      "decisionDate": "2016-02-01",
      "dateReceived": "2015-08-17"
    },
    {
      "kNumber": "K143222",
      "deviceName": "FIREFLY Pedicle Screw Navigation Guide",
      "applicant": "Mighty Oak Medical, Inc.",
      "company": "Mighty Oak Medical",
      "decisionDate": "2015-12-11",
      "dateReceived": "2014-11-10"
    },
    {
      "kNumber": "K150684",
      "deviceName": "WASTON General Spinal System",
      "applicant": "Changzhou Waston Medical Appliance Co., Ltd.",
      "company": "Changzhou Waston Medical Appliance Co., Ltd.",
      "decisionDate": "2015-11-18",
      "dateReceived": "2015-03-17"
    }
  ],
  "topApplicants": [
    {
      "name": "K2m, Inc.",
      "count": 14
    },
    {
      "name": "Medtronic Sofamor Danek, Inc.",
      "count": 12
    },
    {
      "name": "Medtronic Sofamor Danek",
      "count": 11
    },
    {
      "name": "Spine Wave, Inc.",
      "count": 11
    },
    {
      "name": "Spinal USA",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Medtronic Sofamor Danek, Inc.",
      "count": 23,
      "spellings": 2
    },
    {
      "name": "K2M, Inc.",
      "count": 15,
      "spellings": 2
    },
    {
      "name": "Spine Wave, Inc.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Spinal USA, LLC",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Blackstone Medical, Inc.",
      "count": 7,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 54,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 32.662186152672156,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 9.95316709722054,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 11.022218886087488,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 12.248724535802292,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 11.160771274633278,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 11.625239315492154,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 25,
        "expectedLow": 0,
        "expectedHigh": 14.726667173639324,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 18.14079416903113,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 18.133713352145392,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 16.32966318504771,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 13.560808660509636,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 13,
        "expectedLow": 0,
        "expectedHigh": 16.20686017430705,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 12,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "MNI (Orthosis, Spinal Pedicle Fixation) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1773-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1773-2026"
        ],
        "severity": 75
      }
    ],
    "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%3AMNI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMNI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMNI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMNI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMNI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMNI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMNI"
    }
  ],
  "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": "2026-08-11T13:51:45.745Z"
}