{
  "code": "MBI",
  "deviceName": "Fastener, Fixation, Nondegradable, Soft Tissue",
  "deviceClass": "II",
  "regulationNumber": "888.3040",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 597,
    "last12Months": 28
  },
  "adverseEvents": {
    "total": 10312,
    "last12Months": 2668
  },
  "reviewDays": {
    "median": 81,
    "sampleSize": 597
  },
  "recalls": {
    "total": 113,
    "recent": [
      {
        "resNumber": "Z-0212-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Biomet, Inc.",
        "firmAsPublished": "Biomet, Inc.",
        "reason": "There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop",
        "initiated": "2025-09-23"
      },
      {
        "resNumber": "Z-2619-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Biomet, Inc.",
        "firmAsPublished": "Biomet, Inc.",
        "reason": "The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.",
        "initiated": "2025-09-09"
      },
      {
        "resNumber": "Z-1328-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Stryker Corporation",
        "firmAsPublished": "Stryker Corporation",
        "reason": "Increase in complaints concerning \"pullwire\" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.",
        "initiated": "2025-01-29"
      },
      {
        "resNumber": "Z-0581-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Smith & Nephew, Inc.",
        "firmAsPublished": "Smith & Nephew Inc.",
        "reason": "Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.",
        "initiated": "2024-10-29"
      },
      {
        "resNumber": "Z-0518-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Riverpoint Medical, LLC",
        "firmAsPublished": "Riverpoint Medical, LLC",
        "reason": "Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.",
        "initiated": "2023-10-25"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261632",
      "deviceName": "Thunderbolt System",
      "applicant": "Responsive Arthroscopy, Inc.",
      "company": "Responsive Arthroscopy, Inc.",
      "decisionDate": "2026-07-20",
      "dateReceived": "2026-05-18"
    },
    {
      "kNumber": "K261968",
      "deviceName": "Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)",
      "applicant": "Smith & Nephew, Inc.",
      "company": "Smith & Nephew, Inc.",
      "decisionDate": "2026-07-09",
      "dateReceived": "2026-06-11"
    },
    {
      "kNumber": "K260018",
      "deviceName": "Arthrex FiberButton",
      "applicant": "Arthrex, Inc.",
      "company": "Arthrex, Inc.",
      "decisionDate": "2026-06-26",
      "dateReceived": "2026-01-05"
    },
    {
      "kNumber": "K253130",
      "deviceName": "Dione PEEK Screw System",
      "applicant": "ZheJiang Decans Medical Devices Co., Ltd.",
      "company": "ZheJiang Decans Medical Devices Co., Ltd.",
      "decisionDate": "2026-05-27",
      "dateReceived": "2025-09-25"
    },
    {
      "kNumber": "K261363",
      "deviceName": "Y-Knotless™ Flex Anchors",
      "applicant": "CONMED Corporation",
      "company": "Conmed Corporation",
      "decisionDate": "2026-05-13",
      "dateReceived": "2026-04-27"
    },
    {
      "kNumber": "K253027",
      "deviceName": "Anchor with Fiber Wire and Disposable Inserter",
      "applicant": "Ortobio S.A.",
      "company": "Ortobio S.A.",
      "decisionDate": "2026-05-06",
      "dateReceived": "2025-09-19"
    },
    {
      "kNumber": "K252635",
      "deviceName": "ArthroTAK Tendon Anchor Kit",
      "applicant": "ArthroTAK, LLC",
      "company": "ArthroTAK, LLC",
      "decisionDate": "2026-05-01",
      "dateReceived": "2025-08-20"
    },
    {
      "kNumber": "K260921",
      "deviceName": "Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line",
      "applicant": "Tigon Medical",
      "company": "TIGON MEDICAL LLC",
      "decisionDate": "2026-04-21",
      "dateReceived": "2026-03-19"
    },
    {
      "kNumber": "K260561",
      "deviceName": "Arthrex FiberTak Suture Anchor",
      "applicant": "Arthrex, Inc.",
      "company": "Arthrex, Inc.",
      "decisionDate": "2026-03-20",
      "dateReceived": "2026-02-19"
    },
    {
      "kNumber": "K253886",
      "deviceName": "Grappler Suture Anchor PCFD Tether System",
      "applicant": "Paragon 28, Inc.",
      "company": "Paragon 28, Inc.",
      "decisionDate": "2026-03-17",
      "dateReceived": "2025-12-04"
    }
  ],
  "topApplicants": [
    {
      "name": "Arthrex, Inc.",
      "count": 52
    },
    {
      "name": "Innovasive Devices, Inc.",
      "count": 22
    },
    {
      "name": "Parcus Medical, LLC",
      "count": 21
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 20
    },
    {
      "name": "Arthrocare Corp.",
      "count": 18
    }
  ],
  "topCompanies": [
    {
      "name": "Arthrex, Inc.",
      "count": 52,
      "spellings": 1
    },
    {
      "name": "ArthroCare Corporation",
      "count": 31,
      "spellings": 2
    },
    {
      "name": "Parcus Medical, LLC",
      "count": 23,
      "spellings": 2
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 23,
      "spellings": 3
    },
    {
      "name": "Innovasive Devices, Inc.",
      "count": 22,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Ortobio S.A.",
      "since": "2026-05-06",
      "kNumber": "K253027"
    },
    {
      "name": "ArthroTAK, LLC",
      "since": "2026-05-01",
      "kNumber": "K252635"
    },
    {
      "name": "Trax Surgical, Inc.",
      "since": "2026-03-12",
      "kNumber": "K251750"
    },
    {
      "name": "Theramicro",
      "since": "2026-03-06",
      "kNumber": "K253538"
    },
    {
      "name": "GM Dos Reis Industria e Comercio Ltda.",
      "since": "2025-11-04",
      "kNumber": "K252664"
    },
    {
      "name": "Suturetech, Inc.",
      "since": "2025-09-05",
      "kNumber": "K250095"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 144,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 121,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 164,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 153,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 217,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 169,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 251,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 189,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 190,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 294,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 244,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 266,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 317,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 591,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 511,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 231,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 195,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 333,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 285,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 209,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 302,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 217,
        "expectedLow": 14.382152840232221,
        "expectedHigh": 508.5069825236302,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 244,
        "expectedLow": 0,
        "expectedHigh": 434.7758583569008,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 246,
        "expectedLow": 7.88770976831798,
        "expectedHigh": 494.41945366235683,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 404,
        "expectedLow": 6.390454276377018,
        "expectedHigh": 511.075587712247,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 303,
        "expectedLow": 43.34479223703562,
        "expectedHigh": 529.7438592481469,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 332,
        "expectedLow": 101.7261529126702,
        "expectedHigh": 502.20428513982944,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 324,
        "expectedLow": 274.9669789164168,
        "expectedHigh": 688.6526864185408,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 321,
        "expectedLow": 173.03512969574598,
        "expectedHigh": 482.71399447639214,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 349,
        "expectedLow": 199.51941307609405,
        "expectedHigh": 490.80956012786555,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 372,
        "expectedLow": 200.31239952205158,
        "expectedHigh": 485.6541645525528,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 243,
        "expectedLow": 187.79541311890412,
        "expectedHigh": 444.508044368081,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 411,
        "expectedLow": 193.08210207917037,
        "expectedHigh": 461.54715925445294,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 323,
        "expectedLow": 244.63653064086185,
        "expectedHigh": 566.5601662982318,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 400,
        "expectedLow": 190.28241783051737,
        "expectedHigh": 456.0773810996323,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 359,
        "expectedLow": 229.10918853981175,
        "expectedHigh": 529.030196102896,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "MBI (Fastener, Fixation, Nondegradable, Soft Tissue) has three findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0212-2026, Z-2619-2025). 6 first-time filers in the last 12 months, including Ortobio S.A. and ArthroTAK, LLC (K253027, K252635, K251750, K253538, K252664). The code is crowded, scoring 96 of 100 — 145 companies hold a clearance here and 28 arrived in the last 12 months (MBI:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0212-2026",
          "Z-2619-2025"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "6 first-time filers in the last 12 months, including Ortobio S.A. and ArthroTAK, LLC",
        "recordIds": [
          "K253027",
          "K252635",
          "K251750",
          "K253538",
          "K252664"
        ],
        "severity": 46
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 96 of 100 — 145 companies hold a clearance here and 28 arrived in the last 12 months",
        "recordIds": [
          "MBI: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%3AMBI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMBI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMBI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMBI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMBI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMBI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMBI"
    }
  ],
  "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": "2026-08-11T13:51:45.743Z"
}