{
  "code": "MNH",
  "deviceName": "Orthosis, Spondylolisthesis Spinal Fixation",
  "deviceClass": "II",
  "regulationNumber": "888.3070",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 309,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 514,
    "last12Months": 49
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 309
  },
  "recalls": {
    "total": 15,
    "recent": [
      {
        "resNumber": "Z-1884-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "XTANT MEDICAL INC",
        "firmAsPublished": "XTANT MEDICAL INC",
        "reason": "The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.",
        "initiated": "2017-04-12"
      },
      {
        "resNumber": "Z-0883-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Amendia, Inc dba Spinal Elements",
        "firmAsPublished": "Amendia, Inc",
        "reason": "The rods are packaged in packages with unacceptable seals.  In some cases, the integrity of the seal is compromised by channels or voids.",
        "initiated": "2016-11-22"
      },
      {
        "resNumber": "Z-1823-2015",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "X Spine Systems Inc",
        "firmAsPublished": "X Spine Systems Inc",
        "reason": "The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.",
        "initiated": "2015-04-07"
      },
      {
        "resNumber": "Z-1512-2015",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "X Spine Systems Inc",
        "firmAsPublished": "X Spine Systems Inc",
        "reason": "One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.",
        "initiated": "2015-03-11"
      },
      {
        "resNumber": "Z-0938-2013",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Synthes USA HQ, Inc.",
        "firmAsPublished": "Synthes USA HQ, Inc.",
        "reason": "Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as \"Click 'X Pedicle Screw 05.2 L40 TAN violet\" although the actual length of the screw is 45 mm.",
        "initiated": "2013-01-11"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K162066",
      "deviceName": "Reliance Spinal Screw System",
      "applicant": "Reliance Medical Systems, LLC",
      "company": "Reliance Medical Systems, LLC",
      "decisionDate": "2016-12-02",
      "dateReceived": "2016-07-26"
    },
    {
      "kNumber": "K162801",
      "deviceName": "CastleLoc Spinal Fixation System",
      "applicant": "L&K BIOMED Co., Ltd.",
      "company": "L and K Biomed Corporation Limited",
      "decisionDate": "2016-11-03",
      "dateReceived": "2016-10-05"
    },
    {
      "kNumber": "K162143",
      "deviceName": "FixxSure® X-Link",
      "applicant": "Innovasis, Inc.",
      "company": "Innovasis, Inc",
      "decisionDate": "2016-09-23",
      "dateReceived": "2016-08-01"
    },
    {
      "kNumber": "K161151",
      "deviceName": "Spinal fixation system",
      "applicant": "Canwell Medical Co., Ltd.",
      "company": "Canwell Medical Co., Ltd.",
      "decisionDate": "2016-09-21",
      "dateReceived": "2016-04-25"
    },
    {
      "kNumber": "K162189",
      "deviceName": "ANAX™ 5.5 Spinal System",
      "applicant": "U&I Corporation",
      "company": "U&I CORP.",
      "decisionDate": "2016-08-30",
      "dateReceived": "2016-08-04"
    },
    {
      "kNumber": "K151362",
      "deviceName": "HC Spinal System",
      "applicant": "Hung Chun Bio-S Co., Ltd.",
      "company": "Hung Chun Bio-S Co., Ltd.",
      "decisionDate": "2016-05-05",
      "dateReceived": "2015-05-21"
    },
    {
      "kNumber": "K153404",
      "deviceName": "Zavation Spinal System",
      "applicant": "Zavation, LLC",
      "company": "Zavation",
      "decisionDate": "2016-04-21",
      "dateReceived": "2015-11-24"
    },
    {
      "kNumber": "K160020",
      "deviceName": "Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System",
      "applicant": "Captiva Spine",
      "company": "Captiva Spine, Inc",
      "decisionDate": "2016-03-02",
      "dateReceived": "2016-01-05"
    },
    {
      "kNumber": "K143013",
      "deviceName": "Spinal Inner Fixation System",
      "applicant": "Changzhou Dingjian Medical Appliance Co., Ltd.",
      "company": "Changzhou Dingjian Medical Appliance Co., Ltd.",
      "decisionDate": "2015-12-11",
      "dateReceived": "2014-10-20"
    },
    {
      "kNumber": "K151695",
      "deviceName": "Romeo posterior osteosynthesis system",
      "applicant": "Spineart",
      "company": "SPINEART SA",
      "decisionDate": "2015-09-10",
      "dateReceived": "2015-06-23"
    }
  ],
  "topApplicants": [
    {
      "name": "Acromed Corp.",
      "count": 14
    },
    {
      "name": "Depuyacromed",
      "count": 13
    },
    {
      "name": "Medtronic Sofamor Danek, Inc.",
      "count": 13
    },
    {
      "name": "Sofamor Danek USA,Inc.",
      "count": 9
    },
    {
      "name": "Advanced Spine Fixation Systems, Inc.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Medtronic Sofamor Danek, Inc.",
      "count": 17,
      "spellings": 2
    },
    {
      "name": "Acromed Corp.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Depuyacromed",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Howmedica Osteonics Corp.",
      "count": 9,
      "spellings": 2
    },
    {
      "name": "Sofamor Danek USA,Inc.",
      "count": 9,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 34,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 37,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 156,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 95.65471461632838,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 11,
        "expectedLow": 0,
        "expectedHigh": 82.84834261505766,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 21,
        "expectedLow": 0,
        "expectedHigh": 95.49379271265781,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 5,
        "expectedLow": 0.210312796326407,
        "expectedHigh": 24.03739098518082,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 17,
        "expectedLow": 0,
        "expectedHigh": 20.648448506843863,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 24.994765006563313,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 35.31442283437014,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 23.661092218929955,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 23.211660620253962,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 21.97281579742791,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 18.964503028842955,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 20.733018641077837,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 20,
        "expectedLow": 0,
        "expectedHigh": 23.881407255302324,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 24.77012136965456,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 25.91725751256247,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "MNH (Orthosis, Spondylolisthesis Spinal Fixation): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "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%3AMNH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMNH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMNH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMNH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMNH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMNH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMNH"
    }
  ],
  "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": "2026-08-11T13:51:45.744Z"
}