{
  "code": "KTT",
  "deviceName": "Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component",
  "deviceClass": "II",
  "regulationNumber": "888.3030",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 404,
    "last12Months": 10
  },
  "adverseEvents": {
    "total": 1712,
    "last12Months": 285
  },
  "reviewDays": {
    "median": 75,
    "sampleSize": 404
  },
  "recalls": {
    "total": 89,
    "recent": [
      {
        "resNumber": "Z-2827-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Stryker Corporation",
        "firmAsPublished": "Stryker GmbH",
        "reason": "Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.",
        "initiated": "2026-07-01"
      },
      {
        "resNumber": "Z-2828-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Stryker Corporation",
        "firmAsPublished": "Stryker GmbH",
        "reason": "Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.",
        "initiated": "2026-07-01"
      },
      {
        "resNumber": "Z-2829-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Stryker Corporation",
        "firmAsPublished": "Stryker GmbH",
        "reason": "Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.",
        "initiated": "2026-07-01"
      },
      {
        "resNumber": "Z-2830-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Stryker Corporation",
        "firmAsPublished": "Stryker GmbH",
        "reason": "Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.",
        "initiated": "2026-07-01"
      },
      {
        "resNumber": "Z-2831-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Stryker Corporation",
        "firmAsPublished": "Stryker GmbH",
        "reason": "Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.",
        "initiated": "2026-07-01"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K254087",
      "deviceName": "MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System",
      "applicant": "Synthes (USA) Products, LLC",
      "company": "Synthes (USA) Products LLC",
      "decisionDate": "2026-06-11",
      "dateReceived": "2025-12-18"
    },
    {
      "kNumber": "K260900",
      "deviceName": "DYNEX® External Fixation Systems",
      "applicant": "Vilex, LLC",
      "company": "Vilex, Inc.",
      "decisionDate": "2026-04-17",
      "dateReceived": "2026-03-18"
    },
    {
      "kNumber": "K260112",
      "deviceName": "QuikFix External Fixator: Knee-Spanning Pack",
      "applicant": "Stabiliz Orthopaedics, Inc.",
      "company": "Stabiliz Orthopaedics, Inc.",
      "decisionDate": "2026-03-23",
      "dateReceived": "2026-01-14"
    },
    {
      "kNumber": "K253291",
      "deviceName": "Excelsior System",
      "applicant": "Blue Ocean Global",
      "company": "Blue Ocean Global",
      "decisionDate": "2026-01-20",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K253613",
      "deviceName": "Monkey Rings External Ring Fixation System",
      "applicant": "Paragon 28, Inc.",
      "company": "Paragon 28, Inc.",
      "decisionDate": "2025-12-19",
      "dateReceived": "2025-11-18"
    },
    {
      "kNumber": "K253202",
      "deviceName": "Hoffmann LRF System",
      "applicant": "Stryker GmbH",
      "company": "Stryker Corporation",
      "decisionDate": "2025-12-19",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K252555",
      "deviceName": "Medusa Orthopedics Boa External Fixation System",
      "applicant": "Medusa Orthopedics, LLC",
      "company": "Medusa Orthopedics, LLC",
      "decisionDate": "2025-11-25",
      "dateReceived": "2025-08-13"
    },
    {
      "kNumber": "K252625",
      "deviceName": "The Response Ortho Smart Fixator - Hexapod System",
      "applicant": "Response Ortho Solutions, LLC",
      "company": "Response Ortho Solutions, LLC",
      "decisionDate": "2025-11-20",
      "dateReceived": "2025-08-19"
    },
    {
      "kNumber": "K252106",
      "deviceName": "External Fixation Mini Rail System",
      "applicant": "Paragon 28, Inc.",
      "company": "Paragon 28, Inc.",
      "decisionDate": "2025-09-30",
      "dateReceived": "2025-07-03"
    },
    {
      "kNumber": "K251862",
      "deviceName": "External Fixation Bone Distractor",
      "applicant": "Paragon 28, Inc.",
      "company": "Paragon 28, Inc.",
      "decisionDate": "2025-08-11",
      "dateReceived": "2025-06-17"
    }
  ],
  "topApplicants": [
    {
      "name": "Ebi, L.P.",
      "count": 35
    },
    {
      "name": "Synthes (Usa)",
      "count": 31
    },
    {
      "name": "Howmedica Corp.",
      "count": 20
    },
    {
      "name": "Howmedica Osteonics Corp.",
      "count": 19
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 15
    }
  ],
  "topCompanies": [
    {
      "name": "Ebi, L.P.",
      "count": 35,
      "spellings": 1
    },
    {
      "name": "Synthes USA",
      "count": 32,
      "spellings": 2
    },
    {
      "name": "Howmedica Corp.",
      "count": 22,
      "spellings": 2
    },
    {
      "name": "Howmedica Osteonics Corp.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 16,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Stabiliz Orthopaedics, Inc.",
      "since": "2026-03-23",
      "kNumber": "K260112"
    },
    {
      "name": "Blue Ocean Global",
      "since": "2026-01-20",
      "kNumber": "K253291"
    },
    {
      "name": "Medusa Orthopedics, LLC",
      "since": "2025-11-25",
      "kNumber": "K252555"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 50,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 76,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 62,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 31,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 63,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 68,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 43,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 51,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 39,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 33,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 47,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 64,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 29,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 43,
        "expectedLow": null,
        "expectedHigh": null,
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      {
        "month": "2024-12-01",
        "observed": 45,
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        "isSufficient": false
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      {
        "month": "2025-01-01",
        "observed": 35,
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        "expectedHigh": 64.59700198135877,
        "isSufficient": true
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        "month": "2025-02-01",
        "observed": 22,
        "expectedLow": 15.389163742647886,
        "expectedHigh": 50.38582926943133,
        "isSufficient": true
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      {
        "month": "2025-03-01",
        "observed": 50,
        "expectedLow": 12.453224459443613,
        "expectedHigh": 54.08808052398309,
        "isSufficient": true
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      {
        "month": "2025-04-01",
        "observed": 273,
        "expectedLow": 17.93249578586311,
        "expectedHigh": 60.76972302782518,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
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        "expectedHigh": 231.62784724867117,
        "isSufficient": true
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      {
        "month": "2025-06-01",
        "observed": 15,
        "expectedLow": 0,
        "expectedHigh": 214.64536452951236,
        "isSufficient": true
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      {
        "month": "2025-07-01",
        "observed": 35,
        "expectedLow": 0,
        "expectedHigh": 309.15968651079874,
        "isSufficient": true
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      {
        "month": "2025-08-01",
        "observed": 52,
        "expectedLow": 0,
        "expectedHigh": 220.52554514963558,
        "isSufficient": true
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      {
        "month": "2025-09-01",
        "observed": 43,
        "expectedLow": 0,
        "expectedHigh": 230.3293349207444,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 48,
        "expectedLow": 0,
        "expectedHigh": 223.75575097814922,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 19,
        "expectedLow": 0,
        "expectedHigh": 199.51525892201548,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 66,
        "expectedLow": 0,
        "expectedHigh": 213.45558023307694,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 27,
        "expectedLow": 0,
        "expectedHigh": 253.9823810642429,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 22,
        "expectedLow": 0,
        "expectedHigh": 208.1810596800646,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 21,
        "expectedLow": 0,
        "expectedHigh": 223.21728877086346,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Z-2827-2026, Z-2828-2026, Z-2829-2026, Z-2830-2026, Z-2831-2026). 3 first-time filers in the last 12 months, including Stabiliz Orthopaedics, Inc. and Blue Ocean Global (K260112, K253291, K252555). The code is crowded, scoring 88 of 100 — 146 companies hold a clearance here and 10 arrived in the last 12 months (KTT:crowding).",
    "severity": 70,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated",
        "recordIds": [
          "Z-2827-2026",
          "Z-2828-2026",
          "Z-2829-2026",
          "Z-2830-2026",
          "Z-2831-2026"
        ],
        "severity": 70
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Stabiliz Orthopaedics, Inc. and Blue Ocean Global",
        "recordIds": [
          "K260112",
          "K253291",
          "K252555"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 88 of 100 — 146 companies hold a clearance here and 10 arrived in the last 12 months",
        "recordIds": [
          "KTT: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%3AKTT"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKTT"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKTT"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKTT"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKTT"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKTT"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKTT"
    }
  ],
  "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": "2026-08-11T13:51:45.735Z"
}