{
  "code": "MAI",
  "deviceName": "Fastener, Fixation, Biodegradable, Soft Tissue",
  "deviceClass": "II",
  "regulationNumber": "888.3030",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 220,
    "last12Months": 6
  },
  "adverseEvents": {
    "total": 6269,
    "last12Months": 1639
  },
  "reviewDays": {
    "median": 85,
    "sampleSize": 220
  },
  "recalls": {
    "total": 96,
    "recent": [
      {
        "resNumber": "Z-1166-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Aju Pharm Co., Ltd.",
        "firmAsPublished": "Aju Pharm Co., Ltd.",
        "reason": "Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.",
        "initiated": "2025-12-17"
      },
      {
        "resNumber": "Z-1167-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Aju Pharm Co., Ltd.",
        "firmAsPublished": "Aju Pharm Co., Ltd.",
        "reason": "Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.",
        "initiated": "2025-12-17"
      },
      {
        "resNumber": "Z-1168-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Aju Pharm Co., Ltd.",
        "firmAsPublished": "Aju Pharm Co., Ltd.",
        "reason": "Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.",
        "initiated": "2025-12-17"
      },
      {
        "resNumber": "Z-1169-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Aju Pharm Co., Ltd.",
        "firmAsPublished": "Aju Pharm Co., Ltd.",
        "reason": "Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.",
        "initiated": "2025-12-17"
      },
      {
        "resNumber": "Z-1170-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Aju Pharm Co., Ltd.",
        "firmAsPublished": "Aju Pharm Co., Ltd.",
        "reason": "Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.",
        "initiated": "2025-12-17"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253931",
      "deviceName": "Arthrex Bioabsorbable PushLock Suture Anchors",
      "applicant": "Arthrex, Inc.",
      "company": "Arthrex, Inc.",
      "decisionDate": "2026-05-28",
      "dateReceived": "2025-12-09"
    },
    {
      "kNumber": "K260294",
      "deviceName": "SF Push-in Anchor",
      "applicant": "Surgical Fusion Technologies GmbH",
      "company": "Surgical Fusion Technologies GmbH",
      "decisionDate": "2026-03-27",
      "dateReceived": "2026-01-29"
    },
    {
      "kNumber": "K254055",
      "deviceName": "OSSIOfiber® Suture Anchor",
      "applicant": "OSSIO , Ltd.",
      "company": "OSSIO , Ltd.",
      "decisionDate": "2026-02-24",
      "dateReceived": "2025-12-17"
    },
    {
      "kNumber": "K251680",
      "deviceName": "Biosteon® Screw",
      "applicant": "Biocomposites, Ltd.",
      "company": "Biocomposites, Ltd.",
      "decisionDate": "2026-02-17",
      "dateReceived": "2025-05-30"
    },
    {
      "kNumber": "K252946",
      "deviceName": "BioBrace® Extra-Articular Ligament Augmentation Kit",
      "applicant": "Conmed Corporation",
      "company": "Conmed Corporation",
      "decisionDate": "2025-10-15",
      "dateReceived": "2025-09-15"
    },
    {
      "kNumber": "K252022",
      "deviceName": "OSSIOfiber® Interference Screw",
      "applicant": "OSSIO , Ltd.",
      "company": "OSSIO , Ltd.",
      "decisionDate": "2025-08-19",
      "dateReceived": "2025-06-30"
    },
    {
      "kNumber": "K251309",
      "deviceName": "OSSIOfiber® Suture Anchor",
      "applicant": "OSSIO , Ltd.",
      "company": "OSSIO , Ltd.",
      "decisionDate": "2025-05-27",
      "dateReceived": "2025-04-28"
    },
    {
      "kNumber": "K250544",
      "deviceName": "Knotilus+ Biocomposite Knotless Anchor",
      "applicant": "Stryker Endoscopy",
      "company": "Stryker Endoscopy",
      "decisionDate": "2025-05-23",
      "dateReceived": "2025-02-25"
    },
    {
      "kNumber": "K250528",
      "deviceName": "Stryker AlphaVent™ Knotless SP Biocomposite Anchor",
      "applicant": "Stryker Endoscopy",
      "company": "Stryker Endoscopy",
      "decisionDate": "2025-05-21",
      "dateReceived": "2025-02-24"
    },
    {
      "kNumber": "K243760",
      "deviceName": "OSSIOfiber® Suture Anchor 2.5-3.5 mm",
      "applicant": "OSSIO , Ltd.",
      "company": "OSSIO , Ltd.",
      "decisionDate": "2025-04-03",
      "dateReceived": "2024-12-06"
    }
  ],
  "topApplicants": [
    {
      "name": "Arthrex, Inc.",
      "count": 45
    },
    {
      "name": "Depuy Mitek, A Johnson & Johnson Company",
      "count": 18
    },
    {
      "name": "Linvatec Corp.",
      "count": 11
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 10
    },
    {
      "name": "Medos International SARL",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Arthrex, Inc.",
      "count": 45,
      "spellings": 1
    },
    {
      "name": "Depuy Mitek, A Johnson and Johnson Company",
      "count": 20,
      "spellings": 2
    },
    {
      "name": "Linvatec Corp. dba ConMed Linvatec",
      "count": 12,
      "spellings": 2
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 12,
      "spellings": 2
    },
    {
      "name": "Bionx Implants, Inc.",
      "count": 11,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Biocomposites, Ltd.",
      "since": "2026-02-17",
      "kNumber": "K251680"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 88,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 74,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 131,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 125,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 129,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 133,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 133,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 171,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 121,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 190,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 141,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 172,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 237,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 266,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 235,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 197,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 145,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 177,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 185,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 170,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 186,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 157,
        "expectedLow": 84.12920064392429,
        "expectedHigh": 250.39030804179396,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 123,
        "expectedLow": 68.97986084245436,
        "expectedHigh": 215.93996448214926,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 115,
        "expectedLow": 71.49227389041441,
        "expectedHigh": 235.21203016959961,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 184,
        "expectedLow": 55.51596026895163,
        "expectedHigh": 239.5791769169985,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 170,
        "expectedLow": 71.74781411721222,
        "expectedHigh": 225.71901088336358,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 166,
        "expectedLow": 96.89150114231879,
        "expectedHigh": 224.67125929079947,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 188,
        "expectedLow": 192.76533762175626,
        "expectedHigh": 314.5848073646294,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 168,
        "expectedLow": 125.66586162142153,
        "expectedHigh": 226.56379556590724,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 236,
        "expectedLow": 133.28455870342103,
        "expectedHigh": 233.45774904540707,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 247,
        "expectedLow": 141.639814712031,
        "expectedHigh": 253.9139423080659,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 139,
        "expectedLow": 133.26639318300616,
        "expectedHigh": 249.76115126630307,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 228,
        "expectedLow": 125.9861390658417,
        "expectedHigh": 263.854466642266,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 170,
        "expectedLow": 153.35307970543113,
        "expectedHigh": 318.98995094808225,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 313,
        "expectedLow": 107.68622010922809,
        "expectedHigh": 257.7758766030205,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 197,
        "expectedLow": 129.58765573149273,
        "expectedHigh": 355.9225537487987,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "MAI (Fastener, Fixation, Biodegradable, Soft Tissue) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1166-2026, Z-1167-2026, Z-1168-2026, Z-1169-2026, Z-1170-2026). 1 first-time filer in the last 12 months, Biocomposites, Ltd (K251680). The code is crowded, scoring 67 of 100 — 59 companies hold a clearance here and 6 arrived in the last 12 months (MAI:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1166-2026",
          "Z-1167-2026",
          "Z-1168-2026",
          "Z-1169-2026",
          "Z-1170-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Biocomposites, Ltd.",
        "recordIds": [
          "K251680"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 67 of 100 — 59 companies hold a clearance here and 6 arrived in the last 12 months",
        "recordIds": [
          "MAI: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%3AMAI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMAI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMAI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMAI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMAI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMAI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMAI"
    }
  ],
  "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"
}