{
  "code": "KWP",
  "deviceName": "Appliance, Fixation, Spinal Interlaminal",
  "deviceClass": "II",
  "regulationNumber": "888.3050",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 430,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 1302,
    "last12Months": 309
  },
  "reviewDays": {
    "median": 88,
    "sampleSize": 430
  },
  "recalls": {
    "total": 68,
    "recent": [
      {
        "resNumber": "Z-1409-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medtronic Sofamor Danek USA, Inc",
        "firmAsPublished": "Medtronic Sofamor Danek USA Inc",
        "reason": "Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws",
        "initiated": "2023-02-16"
      },
      {
        "resNumber": "Z-1410-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medtronic Sofamor Danek USA, Inc",
        "firmAsPublished": "Medtronic Sofamor Danek USA Inc",
        "reason": "Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws",
        "initiated": "2023-02-16"
      },
      {
        "resNumber": "Z-1411-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medtronic Sofamor Danek USA, Inc",
        "firmAsPublished": "Medtronic Sofamor Danek USA Inc",
        "reason": "Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws",
        "initiated": "2023-02-16"
      },
      {
        "resNumber": "Z-1412-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medtronic Sofamor Danek USA, Inc",
        "firmAsPublished": "Medtronic Sofamor Danek USA Inc",
        "reason": "Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws",
        "initiated": "2023-02-16"
      },
      {
        "resNumber": "Z-1413-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medtronic Sofamor Danek USA, Inc",
        "firmAsPublished": "Medtronic Sofamor Danek USA Inc",
        "reason": "Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws",
        "initiated": "2023-02-16"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K143278",
      "deviceName": "LnK Posterior Cervical Fixation System",
      "applicant": "L&K BIOMED Co., Ltd.",
      "company": "L and K Biomed Corporation Limited",
      "decisionDate": "2015-07-29",
      "dateReceived": "2014-11-14"
    },
    {
      "kNumber": "K150753",
      "deviceName": "OASYS System",
      "applicant": "Stryker Corporation",
      "company": "Stryker Corporation",
      "decisionDate": "2015-06-09",
      "dateReceived": "2015-03-23"
    },
    {
      "kNumber": "K150851",
      "deviceName": "Sure Lok Mini Posterior Cervical/Upper Thoracic System",
      "applicant": "Precision Spine, Inc.",
      "company": "Precision Spine, Inc.",
      "decisionDate": "2015-06-04",
      "dateReceived": "2015-03-31"
    },
    {
      "kNumber": "K142867",
      "deviceName": "Reliance Posterior Cervical-Thoracic System",
      "applicant": "Reliance Medical Systems, LLC",
      "company": "Reliance Medical Systems, LLC",
      "decisionDate": "2015-04-29",
      "dateReceived": "2014-10-01"
    },
    {
      "kNumber": "K150254",
      "deviceName": "Streamline OCT Occipito-Cervico-Thoracic System",
      "applicant": "Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)",
      "company": "Pioneer Surgical Technology, Inc.",
      "decisionDate": "2015-04-28",
      "dateReceived": "2015-02-03"
    },
    {
      "kNumber": "K142253",
      "deviceName": "SOLSTICE OCT System",
      "applicant": "Life Spine, Inc.",
      "company": "Life Spine, Inc.",
      "decisionDate": "2015-04-23",
      "dateReceived": "2014-08-14"
    },
    {
      "kNumber": "K150229",
      "deviceName": "SOLSTICE OCT System",
      "applicant": "Life Spine, Inc.",
      "company": "Life Spine, Inc.",
      "decisionDate": "2015-04-07",
      "dateReceived": "2015-02-02"
    },
    {
      "kNumber": "K143249",
      "deviceName": "SOLSTICE OCT System",
      "applicant": "Life Spine, Inc.",
      "company": "Life Spine, Inc.",
      "decisionDate": "2015-04-07",
      "dateReceived": "2014-11-12"
    },
    {
      "kNumber": "K142741",
      "deviceName": "OASYS System",
      "applicant": "Stryker Corporation",
      "company": "Stryker Corporation",
      "decisionDate": "2015-01-15",
      "dateReceived": "2014-09-24"
    },
    {
      "kNumber": "K142558",
      "deviceName": "Caspian OCT/MESA Mini/DENALI Mini Spinal System",
      "applicant": "K2m",
      "company": "K2M, Inc.",
      "decisionDate": "2014-12-22",
      "dateReceived": "2014-09-11"
    }
  ],
  "topApplicants": [
    {
      "name": "Medtronic Sofamor Danek",
      "count": 25
    },
    {
      "name": "Medtronic Sofamor Danek, Inc.",
      "count": 19
    },
    {
      "name": "Synthes (Usa)",
      "count": 17
    },
    {
      "name": "Danek Medical, Inc.",
      "count": 16
    },
    {
      "name": "Acromed Corp.",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "Medtronic Sofamor Danek, Inc.",
      "count": 44,
      "spellings": 2
    },
    {
      "name": "Synthes USA",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Danek Medical, Inc.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Acromed Corp.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Sofamor Danek USA,Inc.",
      "count": 13,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 38,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 41,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 46,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 76,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 31,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 36,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 62,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 46,
        "expectedLow": 0.634623646774516,
        "expectedHigh": 68.6891896039393,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 33,
        "expectedLow": 3.126249258618223,
        "expectedHigh": 62.70022607481231,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 71,
        "expectedLow": 4.776904701677226,
        "expectedHigh": 70.35263670495671,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 51,
        "expectedLow": 16.519481286264547,
        "expectedHigh": 80.5980084095922,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 28,
        "expectedLow": 15.208582928735057,
        "expectedHigh": 77.30379953116665,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 27,
        "expectedLow": 9.718094005508453,
        "expectedHigh": 74.54635596815808,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 34,
        "expectedLow": 9.0998750568313,
        "expectedHigh": 109.32821953727831,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 39,
        "expectedLow": 0.1797467042633554,
        "expectedHigh": 77.72856952829038,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 32,
        "expectedLow": 1.590673679346715,
        "expectedHigh": 80.74165855540087,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 34,
        "expectedLow": 0,
        "expectedHigh": 77.9023328593094,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 31,
        "expectedLow": 0,
        "expectedHigh": 67.27499864903469,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 52,
        "expectedLow": 0,
        "expectedHigh": 73.45750644477346,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 23,
        "expectedLow": 7.358220940235166,
        "expectedHigh": 87.39553141938688,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 69,
        "expectedLow": 0,
        "expectedHigh": 69.63923442678919,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 47,
        "expectedLow": 6.096569044178627,
        "expectedHigh": 92.36101565461662,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KWP (Appliance, Fixation, Spinal Interlaminal): 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%3AKWP"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKWP"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKWP"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKWP"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKWP"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKWP"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKWP"
    }
  ],
  "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": "2026-08-11T13:51:45.736Z"
}