{
  "code": "HWC",
  "deviceName": "Screw, Fixation, Bone",
  "deviceClass": "II",
  "regulationNumber": "888.3040",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 1061,
    "last12Months": 20
  },
  "adverseEvents": {
    "total": 9954,
    "last12Months": 1843
  },
  "reviewDays": {
    "median": 88,
    "sampleSize": 1061
  },
  "recalls": {
    "total": 388,
    "recent": [
      {
        "resNumber": "Z-2361-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medartis, Inc.",
        "firmAsPublished": "Medartis AG",
        "reason": "The cannulation of the CCS screw is not centered.",
        "initiated": "2026-04-24"
      },
      {
        "resNumber": "Z-1599-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "I.T.S. GmbH",
        "firmAsPublished": "I.T.S. GmbH",
        "reason": "Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).",
        "initiated": "2026-01-23"
      },
      {
        "resNumber": "Z-1606-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "I.T.S. GmbH",
        "firmAsPublished": "I.T.S. GmbH",
        "reason": "Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).",
        "initiated": "2026-01-23"
      },
      {
        "resNumber": "Z-1549-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medartis, Inc.",
        "firmAsPublished": "Medartis AG",
        "reason": "Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.",
        "initiated": "2026-01-09"
      },
      {
        "resNumber": "Z-1550-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medartis, Inc.",
        "firmAsPublished": "Medartis AG",
        "reason": "Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.",
        "initiated": "2026-01-09"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K262075",
      "deviceName": "Lapidus Screw Kit",
      "applicant": "Relja Innovations, LLC",
      "company": "RELJA INNOVATIONS, INC",
      "decisionDate": "2026-07-22",
      "dateReceived": "2026-06-22"
    },
    {
      "kNumber": "K260809",
      "deviceName": "Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System",
      "applicant": "Arthrex, Inc.",
      "company": "Arthrex, Inc.",
      "decisionDate": "2026-06-25",
      "dateReceived": "2026-03-12"
    },
    {
      "kNumber": "K253108",
      "deviceName": "VEOFIX Snap Off Screw",
      "applicant": "Steps Ortho",
      "company": "Steps Ortho",
      "decisionDate": "2026-06-05",
      "dateReceived": "2025-09-24"
    },
    {
      "kNumber": "K261154",
      "deviceName": "CoLink® & CoLag® Non-Sterile Screws",
      "applicant": "In2Bones USA, LLC",
      "company": "In2bones USA, LLC",
      "decisionDate": "2026-05-30",
      "dateReceived": "2026-04-08"
    },
    {
      "kNumber": "K261241",
      "deviceName": "TriMed Compression Screws",
      "applicant": "TriMed, Inc.",
      "company": "TriMed Inc.",
      "decisionDate": "2026-05-14",
      "dateReceived": "2026-04-15"
    },
    {
      "kNumber": "K254215",
      "deviceName": "Arthrex Beaming System",
      "applicant": "Arthrex, Inc.",
      "company": "Arthrex, Inc.",
      "decisionDate": "2026-05-08",
      "dateReceived": "2025-12-29"
    },
    {
      "kNumber": "K254077",
      "deviceName": "OSSIOfiber® Threaded Trimmable Fixation Nail",
      "applicant": "OSSIO , Ltd.",
      "company": "OSSIO , Ltd.",
      "decisionDate": "2026-05-01",
      "dateReceived": "2025-12-18"
    },
    {
      "kNumber": "K260934",
      "deviceName": "TITAN Nail; APTUS K-Wire System",
      "applicant": "Medartis AG",
      "company": "Medartis, Inc.",
      "decisionDate": "2026-04-17",
      "dateReceived": "2026-03-20"
    },
    {
      "kNumber": "K252699",
      "deviceName": "CoAptix S System",
      "applicant": "University of Utah, Department of Orthopaedics",
      "company": "University of Utah, Department of Orthopaedics",
      "decisionDate": "2026-04-10",
      "dateReceived": "2025-08-27"
    },
    {
      "kNumber": "K253042",
      "deviceName": "Tyber Medical Trauma Screw",
      "applicant": "Tyber Medical, LLC",
      "company": "Tyber Medical",
      "decisionDate": "2026-04-03",
      "dateReceived": "2025-09-22"
    }
  ],
  "topApplicants": [
    {
      "name": "Arthrex, Inc.",
      "count": 46
    },
    {
      "name": "Wrightmedicaltechnologyinc",
      "count": 31
    },
    {
      "name": "Synthes (Usa)",
      "count": 30
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 27
    },
    {
      "name": "Biomet, Inc.",
      "count": 24
    }
  ],
  "topCompanies": [
    {
      "name": "Arthrex, Inc.",
      "count": 46,
      "spellings": 1
    },
    {
      "name": "Synthes USA",
      "count": 31,
      "spellings": 2
    },
    {
      "name": "Wrightmedicaltechnologyinc",
      "count": 31,
      "spellings": 1
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 27,
      "spellings": 1
    },
    {
      "name": "Biomet, Inc.",
      "count": 24,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Steps Ortho",
      "since": "2026-06-05",
      "kNumber": "K253108"
    },
    {
      "name": "Pace Surgical",
      "since": "2025-11-06",
      "kNumber": "K251555"
    },
    {
      "name": "Orthonovis, Inc.",
      "since": "2025-10-02",
      "kNumber": "K252758"
    },
    {
      "name": "Astra Orthomed, Inc.",
      "since": "2025-08-27",
      "kNumber": "K251382"
    },
    {
      "name": "Dunamis Medical, LLC",
      "since": "2025-08-15",
      "kNumber": "K250867"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 295,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 267,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 300,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 275,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 325,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 308,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 322,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 355,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 261,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 367,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 356,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 247,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 460,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 490,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 215,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 194,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 222,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 335,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 288,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 189,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 212,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 249,
        "expectedLow": 14.102869808250443,
        "expectedHigh": 436.60431494732074,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 157,
        "expectedLow": 22.062423845067197,
        "expectedHigh": 382.75862647974816,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 174,
        "expectedLow": 7.500581238675613,
        "expectedHigh": 412.27733005462227,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 258,
        "expectedLow": 0,
        "expectedHigh": 423.4290562832463,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 280,
        "expectedLow": 53.963015872357474,
        "expectedHigh": 365.1862912148499,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 217,
        "expectedLow": 140.1862217543952,
        "expectedHigh": 331.83367754368976,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 274,
        "expectedLow": 210.29044755152603,
        "expectedHigh": 511.5650666343198,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 207,
        "expectedLow": 141.2956676828103,
        "expectedHigh": 365.697000238025,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 223,
        "expectedLow": 132.8870686556445,
        "expectedHigh": 375.14141449089544,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 227,
        "expectedLow": 140.76309105098838,
        "expectedHigh": 343.34022708688934,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 332,
        "expectedLow": 124.33327899042042,
        "expectedHigh": 301.58085071537454,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 228,
        "expectedLow": 159.9010604384637,
        "expectedHigh": 391.72196873806035,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 170,
        "expectedLow": 168.82291906595097,
        "expectedHigh": 436.85498975033215,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 293,
        "expectedLow": 93.89196729656304,
        "expectedHigh": 348.7850057383508,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 237,
        "expectedLow": 124.97502440858614,
        "expectedHigh": 407.40909550705453,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "HWC (Screw, Fixation, Bone) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2361-2026, Z-1599-2026, Z-1606-2026, Z-1549-2026, Z-1550-2026). 5 first-time filers in the last 12 months, including Steps Ortho and Pace Surgical (K253108, K251555, K252758, K251382, K250867). The code is crowded, scoring 98 of 100 — 349 companies hold a clearance here and 20 arrived in the last 12 months (HWC:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2361-2026",
          "Z-1599-2026",
          "Z-1606-2026",
          "Z-1549-2026",
          "Z-1550-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "5 first-time filers in the last 12 months, including Steps Ortho and Pace Surgical",
        "recordIds": [
          "K253108",
          "K251555",
          "K252758",
          "K251382",
          "K250867"
        ],
        "severity": 45
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 98 of 100 — 349 companies hold a clearance here and 20 arrived in the last 12 months",
        "recordIds": [
          "HWC: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%3AHWC"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHWC"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHWC"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHWC"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHWC"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHWC"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHWC"
    }
  ],
  "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"
}