{
  "code": "JDR",
  "deviceName": "Staple, Fixation, Bone",
  "deviceClass": "II",
  "regulationNumber": "888.3030",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 231,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 704,
    "last12Months": 240
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 231
  },
  "recalls": {
    "total": 36,
    "recent": [
      {
        "resNumber": "Z-2355-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "In2bones USA, LLC",
        "firmAsPublished": "In2bones USA, LLC",
        "reason": "Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.",
        "initiated": "2026-05-11"
      },
      {
        "resNumber": "Z-0098-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Synthes (USA) Products LLC",
        "firmAsPublished": "Synthes (USA) Products LLC",
        "reason": "The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.",
        "initiated": "2022-09-27"
      },
      {
        "resNumber": "Z-0099-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Synthes (USA) Products LLC",
        "firmAsPublished": "Synthes (USA) Products LLC",
        "reason": "The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.",
        "initiated": "2022-09-27"
      },
      {
        "resNumber": "Z-0100-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Synthes (USA) Products LLC",
        "firmAsPublished": "Synthes (USA) Products LLC",
        "reason": "The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.",
        "initiated": "2022-09-27"
      },
      {
        "resNumber": "Z-0101-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Synthes (USA) Products LLC",
        "firmAsPublished": "Synthes (USA) Products LLC",
        "reason": "The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.",
        "initiated": "2022-09-27"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K250712",
      "deviceName": "Linkt Compression Staple System",
      "applicant": "Trax Surgical",
      "company": "Trax Surgical, Inc.",
      "decisionDate": "2025-05-14",
      "dateReceived": "2025-03-10"
    },
    {
      "kNumber": "K243888",
      "deviceName": "Medline UNITE®  REFLEX®  Hybrid Nitinol Implant System",
      "applicant": "Medline Industries, LP",
      "company": "Medline Industries, LP",
      "decisionDate": "2025-04-11",
      "dateReceived": "2024-12-18"
    },
    {
      "kNumber": "K243742",
      "deviceName": "Arthrex DynaNite Nitinol Staples",
      "applicant": "Arthrex, Inc.",
      "company": "Arthrex, Inc.",
      "decisionDate": "2025-01-31",
      "dateReceived": "2024-12-04"
    },
    {
      "kNumber": "K243658",
      "deviceName": "TMC Compression Implant System",
      "applicant": "Treace Medical Concepts",
      "company": "Treace Medical Concepts, Inc.",
      "decisionDate": "2024-12-26",
      "dateReceived": "2024-11-27"
    },
    {
      "kNumber": "K242415",
      "deviceName": "TMC Compression Implant System",
      "applicant": "Treace Medical Concepts",
      "company": "Treace Medical Concepts, Inc.",
      "decisionDate": "2024-09-06",
      "dateReceived": "2024-08-15"
    },
    {
      "kNumber": "K240212",
      "deviceName": "COGNiTiON™ Staple System",
      "applicant": "Ortho Solutions UK , Ltd.",
      "company": "Ortho Solutions UK Limited",
      "decisionDate": "2024-02-23",
      "dateReceived": "2024-01-25"
    },
    {
      "kNumber": "K232990",
      "deviceName": "A’TOMIC™ Nitinol Fixation System",
      "applicant": "Rmr Ortho, LLC",
      "company": "RMR ORTHO, Inc",
      "decisionDate": "2024-01-12",
      "dateReceived": "2023-09-22"
    },
    {
      "kNumber": "K230724",
      "deviceName": "arcad® 2.0 Duo & Quadro osteosynthesis compressive staples",
      "applicant": "Novastep",
      "company": "Novastep SAS",
      "decisionDate": "2023-12-04",
      "dateReceived": "2023-03-16"
    },
    {
      "kNumber": "K232905",
      "deviceName": "Medline UNITE® REFLEX® Nitinol Staple Kit",
      "applicant": "Medline Industries, LP",
      "company": "Medline Industries, LP",
      "decisionDate": "2023-10-19",
      "dateReceived": "2023-09-19"
    },
    {
      "kNumber": "K232324",
      "deviceName": "StealthFix Intraosseous Fixation System",
      "applicant": "Medartis, Inc.",
      "company": "Medartis, Inc.",
      "decisionDate": "2023-08-30",
      "dateReceived": "2023-08-03"
    }
  ],
  "topApplicants": [
    {
      "name": "Mitek Surgical Products, Inc.",
      "count": 16
    },
    {
      "name": "Acufex Microsurgical, Inc.",
      "count": 9
    },
    {
      "name": "Depuy Mitek, A Johnson & Johnson Company",
      "count": 7
    },
    {
      "name": "Biomedical Ent., Inc.",
      "count": 6
    },
    {
      "name": "Arthrex, Inc.",
      "count": 5
    }
  ],
  "topCompanies": [
    {
      "name": "Mitek Surgical Products, Inc.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Acufex Microsurgical, Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Depuy Mitek, A Johnson and Johnson Company",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Biomedical Ent., Inc.",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Arthrex, Inc.",
      "count": 5,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 31,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 11,
        "expectedLow": 6.062155801531037,
        "expectedHigh": 28.093974464073007,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 8,
        "expectedLow": 3.5420350747543887,
        "expectedHigh": 23.131977390102776,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 18,
        "expectedLow": 1.558405110783434,
        "expectedHigh": 24.82786841149944,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 22,
        "expectedLow": 3.478350397441686,
        "expectedHigh": 26.749663068919446,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 35,
        "expectedLow": 4.939547797608007,
        "expectedHigh": 27.24161832730498,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 12,
        "expectedLow": 5.720286665181006,
        "expectedHigh": 39.3522962231602,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 10,
        "expectedLow": 3.500495682604807,
        "expectedHigh": 57.04820006625047,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 11,
        "expectedLow": 0,
        "expectedHigh": 38.89305899707712,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 139,
        "expectedLow": 0,
        "expectedHigh": 38.957114346852386,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 11,
        "expectedLow": 0,
        "expectedHigh": 124.74066609052382,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 11,
        "expectedLow": 0,
        "expectedHigh": 101.53483704989733,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 25,
        "expectedLow": 0,
        "expectedHigh": 104.29504964308698,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 18,
        "expectedLow": 0,
        "expectedHigh": 117.60096954244294,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 14,
        "expectedLow": 0,
        "expectedHigh": 95.13596295320596,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 14,
        "expectedLow": 0,
        "expectedHigh": 100.60399259234977,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "JDR (Staple, Fixation, Bone) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2355-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2355-2026"
        ],
        "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%3AJDR"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJDR"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJDR"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJDR"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJDR"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJDR"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJDR"
    }
  ],
  "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": "2026-08-11T13:51:45.717Z"
}