{
  "code": "HSB",
  "deviceName": "Rod, Fixation, Intramedullary And Accessories",
  "deviceClass": "II",
  "regulationNumber": "888.3020",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 530,
    "last12Months": 22
  },
  "adverseEvents": {
    "total": 7924,
    "last12Months": 1777
  },
  "reviewDays": {
    "median": 86,
    "sampleSize": 530
  },
  "recalls": {
    "total": 690,
    "recent": [
      {
        "resNumber": "Z-2456-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Smith & Nephew, Inc.",
        "firmAsPublished": "Smith & Nephew, Inc.",
        "reason": "Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.",
        "initiated": "2026-03-16"
      },
      {
        "resNumber": "Z-0967-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.",
        "initiated": "2025-12-02"
      },
      {
        "resNumber": "Z-0968-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.",
        "initiated": "2025-12-02"
      },
      {
        "resNumber": "Z-0969-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.",
        "initiated": "2025-12-02"
      },
      {
        "resNumber": "Z-0970-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.",
        "initiated": "2025-12-02"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261481",
      "deviceName": "Pangea Femur Reconstruction System",
      "applicant": "Stryker GmbH",
      "company": "Stryker Corporation",
      "decisionDate": "2026-06-29",
      "dateReceived": "2026-05-05"
    },
    {
      "kNumber": "K261651",
      "deviceName": "Precice™ Max System and Precice™ Ankle Salvage System",
      "applicant": "NuVasive Specialized Orthopedics",
      "company": "NuVasive Specialized Orthopedics, Inc.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2026-05-19"
    },
    {
      "kNumber": "K253080",
      "deviceName": "AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)",
      "applicant": "Suzhou and Science & Technology Development Corp.",
      "company": "Suzhou and Science & Technology Development Corp.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2025-09-23"
    },
    {
      "kNumber": "K253155",
      "deviceName": "Fule Metallic Lockable Intramedullary Nail Systems",
      "applicant": "Beijing Fule Science & Technology Development Co., Ltd.",
      "company": "Beijing Fule Science & Technology Development Co., Ltd.",
      "decisionDate": "2026-06-17",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K253046",
      "deviceName": "HERA Interlocking Intramedullary Nailing System",
      "applicant": "ZheJiang Decans Medical Devices Co., Ltd.",
      "company": "ZheJiang Decans Medical Devices Co., Ltd.",
      "decisionDate": "2026-06-16",
      "dateReceived": "2025-09-22"
    },
    {
      "kNumber": "K260146",
      "deviceName": "FITBONE® TRANSPORT AND LENGTHENING SYSTEM",
      "applicant": "Orthofix Srl",
      "company": "Orthofix, Inc.",
      "decisionDate": "2026-05-19",
      "dateReceived": "2026-01-20"
    },
    {
      "kNumber": "K253991",
      "deviceName": "Fitbone™ Trochanteric,  FITBONE® Transport and Lengthening System,  FITBONE® TAA",
      "applicant": "Orthofix Srl",
      "company": "Orthofix, Inc.",
      "decisionDate": "2026-05-08",
      "dateReceived": "2025-12-12"
    },
    {
      "kNumber": "K261043",
      "deviceName": "AUTOBAHN™ Nailing System",
      "applicant": "Globus Medical, Inc.",
      "company": "Globus Medical, Inc.",
      "decisionDate": "2026-04-24",
      "dateReceived": "2026-03-31"
    },
    {
      "kNumber": "K252016",
      "deviceName": "Arthrex Humeral Nails",
      "applicant": "Arthrex, Inc.",
      "company": "Arthrex, Inc.",
      "decisionDate": "2026-03-20",
      "dateReceived": "2025-06-27"
    },
    {
      "kNumber": "K252961",
      "deviceName": "Fusion FibFix Nail",
      "applicant": "Fusion Orthopedics USA, LLC",
      "company": "Fusion Orthopedics USA, LLC",
      "decisionDate": "2026-03-18",
      "dateReceived": "2025-09-16"
    }
  ],
  "topApplicants": [
    {
      "name": "Howmedica Osteonics Corp.",
      "count": 38
    },
    {
      "name": "Howmedica Corp.",
      "count": 23
    },
    {
      "name": "Synthes (Usa)",
      "count": 22
    },
    {
      "name": "Zimmer, Inc.",
      "count": 17
    },
    {
      "name": "Nuvasive Specialized Orthopedics, Inc.",
      "count": 16
    }
  ],
  "topCompanies": [
    {
      "name": "Howmedica Osteonics Corp.",
      "count": 39,
      "spellings": 2
    },
    {
      "name": "Howmedica Corp.",
      "count": 26,
      "spellings": 2
    },
    {
      "name": "Synthes USA",
      "count": 23,
      "spellings": 2
    },
    {
      "name": "Zimmer, Inc.",
      "count": 23,
      "spellings": 2
    },
    {
      "name": "NuVasive Specialized Orthopedics, Inc.",
      "count": 18,
      "spellings": 3
    }
  ],
  "newEntrants": [
    {
      "name": "Suzhou and Science & Technology Development Corp.",
      "since": "2026-06-18",
      "kNumber": "K253080"
    },
    {
      "name": "Beijing Fule Science & Technology Development Co., Ltd.",
      "since": "2026-06-17",
      "kNumber": "K253155"
    },
    {
      "name": "ZheJiang Decans Medical Devices Co., Ltd.",
      "since": "2026-06-16",
      "kNumber": "K253046"
    },
    {
      "name": "Fusion Orthopedics USA, LLC",
      "since": "2026-03-18",
      "kNumber": "K252961"
    },
    {
      "name": "Reselute, Inc.",
      "since": "2026-03-10",
      "kNumber": "K253517"
    },
    {
      "name": "Satori Orthopaedics, Inc.",
      "since": "2026-03-04",
      "kNumber": "K252025"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 111,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 199,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 148,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 219,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 184,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 208,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 193,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 200,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 164,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 193,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 152,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 188,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 186,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 235,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 230,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 655,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 286,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 208,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 204,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 153,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 179,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 252,
        "expectedLow": 0,
        "expectedHigh": 426.90459164314353,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 184,
        "expectedLow": 0,
        "expectedHigh": 385.60986670293084,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 170,
        "expectedLow": 0,
        "expectedHigh": 427.061152823681,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 184,
        "expectedLow": 0,
        "expectedHigh": 431.2876599981378,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 194,
        "expectedLow": 0,
        "expectedHigh": 400.24539377558216,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 225,
        "expectedLow": 0,
        "expectedHigh": 418.4632184232491,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 351,
        "expectedLow": 0,
        "expectedHigh": 679.0864869228736,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 132,
        "expectedLow": 164.72226440911746,
        "expectedHigh": 330.8397220437528,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 186,
        "expectedLow": 126.42215876636519,
        "expectedHigh": 319.9065395271557,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 451,
        "expectedLow": 110.88958015176011,
        "expectedHigh": 309.7881015769927,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 188,
        "expectedLow": 107.14148338909085,
        "expectedHigh": 401.06880230457244,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 320,
        "expectedLow": 101.7152045144995,
        "expectedHigh": 418.12904327745105,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 167,
        "expectedLow": 138.67538213770834,
        "expectedHigh": 506.28741998208415,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 171,
        "expectedLow": 67.94818063318736,
        "expectedHigh": 397.38777625755245,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 193,
        "expectedLow": 48.75700037826313,
        "expectedHigh": 419.50299186781524,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "HSB (Rod, Fixation, Intramedullary And Accessories) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2456-2026, Z-0967-2026, Z-0968-2026, Z-0969-2026, Z-0970-2026). 6 first-time filers in the last 12 months, including Suzhou and Science & Technology Development Corp. and Beijing Fule Science & Technology Development Co., Ltd (K253080, K253155, K253046, K252961, K253517). Clearances are running 38% slower — a median 119 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days) (HSB:review_time:12m). The code is crowded, scoring 97 of 100 — 159 companies hold a clearance here and 22 arrived in the last 12 months (HSB:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2456-2026",
          "Z-0967-2026",
          "Z-0968-2026",
          "Z-0969-2026",
          "Z-0970-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "6 first-time filers in the last 12 months, including Suzhou and Science & Technology Development Corp. and Beijing Fule Science & Technology Development Co., Ltd.",
        "recordIds": [
          "K253080",
          "K253155",
          "K253046",
          "K252961",
          "K253517"
        ],
        "severity": 46
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 38% slower — a median 119 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "HSB:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 97 of 100 — 159 companies hold a clearance here and 22 arrived in the last 12 months",
        "recordIds": [
          "HSB: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%3AHSB"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHSB"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHSB"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHSB"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHSB"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHSB"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHSB"
    }
  ],
  "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": "2026-08-11T13:51:45.710Z"
}