{
  "code": "KWQ",
  "deviceName": "Appliance, Fixation, Spinal Intervertebral Body",
  "deviceClass": "II",
  "regulationNumber": "888.3060",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 667,
    "last12Months": 11
  },
  "adverseEvents": {
    "total": 997,
    "last12Months": 177
  },
  "reviewDays": {
    "median": 84,
    "sampleSize": 667
  },
  "recalls": {
    "total": 214,
    "recent": [
      {
        "resNumber": "Z-1821-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Clariance Inc",
        "firmAsPublished": "Clariance-SAS",
        "reason": "Due to a quality issue regarding the presence of burr on the finished cervical plate product.",
        "initiated": "2026-02-20"
      },
      {
        "resNumber": "Z-1799-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Alphatec Spine, Inc.",
        "firmAsPublished": "Alphatec Spine, Inc.",
        "reason": "There is a potential for the screw blocking mechanism on the  anterior cervical plate system  to disassociate intraoperatively/postoperatively or unlock postoperatively.",
        "initiated": "2021-04-26"
      },
      {
        "resNumber": "Z-1800-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Alphatec Spine, Inc.",
        "firmAsPublished": "Alphatec Spine, Inc.",
        "reason": "There is a potential for the screw blocking mechanism on the  anterior cervical plate system  to disassociate intraoperatively/postoperatively or unlock postoperatively.",
        "initiated": "2021-04-26"
      },
      {
        "resNumber": "Z-1801-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Alphatec Spine, Inc.",
        "firmAsPublished": "Alphatec Spine, Inc.",
        "reason": "There is a potential for the screw blocking mechanism on the  anterior cervical plate system  to disassociate intraoperatively/postoperatively or unlock postoperatively.",
        "initiated": "2021-04-26"
      },
      {
        "resNumber": "Z-1802-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Alphatec Spine, Inc.",
        "firmAsPublished": "Alphatec Spine, Inc.",
        "reason": "There is a potential for the screw blocking mechanism on the  anterior cervical plate system  to disassociate intraoperatively/postoperatively or unlock postoperatively.",
        "initiated": "2021-04-26"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261309",
      "deviceName": "Palisades™ Buttress Plate System",
      "applicant": "Bethesda Medical Devices, LLC",
      "company": "Bethesda Medical Devices, LLC",
      "decisionDate": "2026-07-16",
      "dateReceived": "2026-04-21"
    },
    {
      "kNumber": "K252776",
      "deviceName": "ARIES Anterior Cervical Plate Systems",
      "applicant": "ZheJiang Decans Medical Devices Co., Ltd.",
      "company": "ZheJiang Decans Medical Devices Co., Ltd.",
      "decisionDate": "2026-05-14",
      "dateReceived": "2025-09-02"
    },
    {
      "kNumber": "K261112",
      "deviceName": "CastleLoc-P Anterior Cervical Plate System",
      "applicant": "L&K BIOMED Co., Ltd.",
      "company": "L and K Biomed Corporation Limited",
      "decisionDate": "2026-05-06",
      "dateReceived": "2026-04-03"
    },
    {
      "kNumber": "K260570",
      "deviceName": "corra™ cervical plating system",
      "applicant": "Carlsmed, Inc.",
      "company": "Carlsmed, Inc.",
      "decisionDate": "2026-04-22",
      "dateReceived": "2026-02-19"
    },
    {
      "kNumber": "K260697",
      "deviceName": "VyPlate™ Anterior Cervical Plate System",
      "applicant": "Vy Spine, LLC",
      "company": "Vy Spine, LLC",
      "decisionDate": "2026-03-27",
      "dateReceived": "2026-03-04"
    },
    {
      "kNumber": "K260015",
      "deviceName": "ANTERIS Thoracolumbar Plate System",
      "applicant": "SpineCraft",
      "company": "Spinecraft, Inc.",
      "decisionDate": "2026-03-04",
      "dateReceived": "2026-01-05"
    },
    {
      "kNumber": "K251940",
      "deviceName": "PathLoc Lumbar Plate System",
      "applicant": "L&K BIOMED Co., Ltd.",
      "company": "L and K Biomed Corporation Limited",
      "decisionDate": "2026-03-03",
      "dateReceived": "2025-06-24"
    },
    {
      "kNumber": "K254182",
      "deviceName": "Aster",
      "applicant": "Osteonic Co., Ltd.",
      "company": "Osteonic Co., Ltd.",
      "decisionDate": "2026-02-26",
      "dateReceived": "2025-12-23"
    },
    {
      "kNumber": "K253201",
      "deviceName": "Lumbar Spine Truss System - Plating Solution (LSTS-PS)",
      "applicant": "4Web, Inc.",
      "company": "4Web, Inc.",
      "decisionDate": "2026-02-12",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K252611",
      "deviceName": "aprevo® cervical plating system",
      "applicant": "Carlsmed, Inc.",
      "company": "Carlsmed, Inc.",
      "decisionDate": "2025-12-22",
      "dateReceived": "2025-08-18"
    }
  ],
  "topApplicants": [
    {
      "name": "Nuvasive, Inc.",
      "count": 21
    },
    {
      "name": "Globus Medical, Inc.",
      "count": 15
    },
    {
      "name": "K2m, Inc.",
      "count": 15
    },
    {
      "name": "Blackstone Medical, Inc.",
      "count": 13
    },
    {
      "name": "Medtronic Sofamor Danek",
      "count": 13
    }
  ],
  "topCompanies": [
    {
      "name": "NuVasive Inc",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "K2M, Inc.",
      "count": 20,
      "spellings": 3
    },
    {
      "name": "Medtronic Sofamor Danek, Inc.",
      "count": 20,
      "spellings": 2
    },
    {
      "name": "Globus Medical, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Life Spine, Inc.",
      "count": 14,
      "spellings": 3
    }
  ],
  "newEntrants": [
    {
      "name": "Bethesda Medical Devices, LLC",
      "since": "2026-07-16",
      "kNumber": "K261309"
    },
    {
      "name": "ZheJiang Decans Medical Devices Co., Ltd.",
      "since": "2026-05-14",
      "kNumber": "K252776"
    },
    {
      "name": "Osteonic Co., Ltd.",
      "since": "2026-02-26",
      "kNumber": "K254182"
    },
    {
      "name": "Carlsmed, Inc.",
      "since": "2025-12-22",
      "kNumber": "K252611"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 31,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 35,
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        "isSufficient": false
      },
      {
        "month": "2023-04-01",
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        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 49,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 29,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 78,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 37,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 44,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 41,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 37,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 42,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 29,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 22,
        "expectedLow": 0,
        "expectedHigh": 62.72798526434046,
        "isSufficient": true
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      {
        "month": "2025-02-01",
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        "expectedHigh": 52.639121871686605,
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      {
        "month": "2025-03-01",
        "observed": 19,
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        "expectedHigh": 58.0559314611991,
        "isSufficient": true
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        "month": "2025-04-01",
        "observed": 29,
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        "expectedHigh": 42.986360504195396,
        "isSufficient": true
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        "month": "2025-05-01",
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        "expectedHigh": 41.259383948074486,
        "isSufficient": true
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      {
        "month": "2025-06-01",
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        "expectedHigh": 39.364852866217575,
        "isSufficient": true
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        "month": "2025-07-01",
        "observed": 22,
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        "expectedHigh": 53.90097599817088,
        "isSufficient": true
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      {
        "month": "2025-08-01",
        "observed": 23,
        "expectedLow": 6.369580432440336,
        "expectedHigh": 37.5534007292877,
        "isSufficient": true
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      {
        "month": "2025-09-01",
        "observed": 13,
        "expectedLow": 7.122342563156356,
        "expectedHigh": 39.751895994469315,
        "isSufficient": true
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        "month": "2025-10-01",
        "observed": 18,
        "expectedLow": 2.2718764736794013,
        "expectedHigh": 38.08798001180546,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 30,
        "expectedLow": 1.3181551718916955,
        "expectedHigh": 34.47972872615245,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 16,
        "expectedLow": 10.288080764336145,
        "expectedHigh": 36.992483233329466,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 16,
        "expectedLow": 9.363041126120837,
        "expectedHigh": 39.74823978623693,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 32,
        "expectedLow": 5.0501937482071115,
        "expectedHigh": 31.994847309093565,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 33,
        "expectedLow": 8.494638061971813,
        "expectedHigh": 41.0650446744265,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KWQ (Appliance, Fixation, Spinal Intervertebral Body) has four findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1821-2026). 4 first-time filers in the last 12 months, including Bethesda Medical Devices, LLC and ZheJiang Decans Medical Devices Co., Ltd (K261309, K252776, K254182, K252611). Clearances are running 23% faster — a median 65 days over the last 12 months against 84 days all-time (elapsed calendar days, not FDA review days) (KWQ:review_time:12m). The code is crowded, scoring 94 of 100 — 244 companies hold a clearance here and 11 arrived in the last 12 months (KWQ:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1821-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "4 first-time filers in the last 12 months, including Bethesda Medical Devices, LLC and ZheJiang Decans Medical Devices Co., Ltd.",
        "recordIds": [
          "K261309",
          "K252776",
          "K254182",
          "K252611"
        ],
        "severity": 44
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 23% faster — a median 65 days over the last 12 months against 84 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "KWQ:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 94 of 100 — 244 companies hold a clearance here and 11 arrived in the last 12 months",
        "recordIds": [
          "KWQ: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%3AKWQ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKWQ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKWQ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKWQ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKWQ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKWQ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKWQ"
    }
  ],
  "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"
}