{
  "code": "MAX",
  "deviceName": "Intervertebral Fusion Device With Bone Graft, Lumbar",
  "deviceClass": "II",
  "regulationNumber": "888.3080",
  "panel": "Orthopedic",
  "definition": "Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 894,
    "last12Months": 22
  },
  "adverseEvents": {
    "total": 2160,
    "last12Months": 465
  },
  "reviewDays": {
    "median": 106,
    "sampleSize": 894
  },
  "recalls": {
    "total": 115,
    "recent": [
      {
        "resNumber": "Z-0892-2026",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "firm": "Orthofix U.S. LLC",
        "firmAsPublished": "Orthofix U.S. LLC",
        "reason": "Labeling contains claims that are not consistently  present.",
        "initiated": "2025-11-03"
      },
      {
        "resNumber": "Z-0895-2026",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "firm": "Orthofix U.S. LLC",
        "firmAsPublished": "Orthofix U.S. LLC",
        "reason": "Labeling contains claims that are not consistently  present.",
        "initiated": "2025-11-03"
      },
      {
        "resNumber": "Z-1038-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medicrea International",
        "firmAsPublished": "Medicrea International",
        "reason": "Due to complaints, orthopedic  rotation tool handle may untread from the shaft resulting in the inability to rotate implant.",
        "initiated": "2025-10-29"
      },
      {
        "resNumber": "Z-1039-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medicrea International",
        "firmAsPublished": "Medicrea International",
        "reason": "Due to complaints, orthopedic  rotation tool handle may untread from the shaft resulting in the inability to rotate implant.",
        "initiated": "2025-10-29"
      },
      {
        "resNumber": "Z-0580-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medtronic Sofamor Danek USA, Inc",
        "firmAsPublished": "Medtronic Sofamor Danek USA Inc",
        "reason": "Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.",
        "initiated": "2025-09-16"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253011",
      "deviceName": "Catalyft PL Expandable Interbody System",
      "applicant": "Medtronic Sofamor Danek USA, Inc.",
      "company": "Medtronic Sofamor Danek USA, Inc",
      "decisionDate": "2026-07-17",
      "dateReceived": "2025-09-19"
    },
    {
      "kNumber": "K261020",
      "deviceName": "Symmetrix™ L Spinal System",
      "applicant": "Medtronic Sofamor Danek USA, Inc.",
      "company": "Medtronic Sofamor Danek USA, Inc",
      "decisionDate": "2026-07-14",
      "dateReceived": "2026-03-27"
    },
    {
      "kNumber": "K253420",
      "deviceName": "Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy",
      "applicant": "SeaSpine Orthopedics Corporation",
      "company": "SEASPINE ORTHOPEDICS CORPORATION",
      "decisionDate": "2026-07-01",
      "dateReceived": "2025-10-01"
    },
    {
      "kNumber": "K253151",
      "deviceName": "Fule Interbody Fusion Cage System",
      "applicant": "Beijing Fule Science & Technology Development Co., Ltd.",
      "company": "Beijing Fule Science & Technology Development Co., Ltd.",
      "decisionDate": "2026-06-15",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K261159",
      "deviceName": "Exceed® Biplanar Expandable Interbody System",
      "applicant": "Spine Wave, Inc.",
      "company": "Spine Wave, Inc.",
      "decisionDate": "2026-05-29",
      "dateReceived": "2026-04-08"
    },
    {
      "kNumber": "K253894",
      "deviceName": "BMD Titanium Spinal Fusion System",
      "applicant": "Global Biomedica s.r.o.",
      "company": "Global Biomedica s.r.o.",
      "decisionDate": "2026-05-28",
      "dateReceived": "2025-12-04"
    },
    {
      "kNumber": "K260506",
      "deviceName": "Ventana® P/T Lumbar Interbody System",
      "applicant": "Spinal Elements, Inc.",
      "company": "Spinal Elements",
      "decisionDate": "2026-05-15",
      "dateReceived": "2026-02-17"
    },
    {
      "kNumber": "K260837",
      "deviceName": "VersaLift Expandable System",
      "applicant": "Life Spine, Inc.",
      "company": "Life Spine, Inc.",
      "decisionDate": "2026-05-12",
      "dateReceived": "2026-03-13"
    },
    {
      "kNumber": "K260385",
      "deviceName": "aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system",
      "applicant": "Carlsmed, Inc.",
      "company": "Carlsmed, Inc.",
      "decisionDate": "2026-05-09",
      "dateReceived": "2026-02-06"
    },
    {
      "kNumber": "K261067",
      "deviceName": "BEE PLIF Cage",
      "applicant": "NGMedical GmbH",
      "company": "NGMedical GmbH",
      "decisionDate": "2026-04-30",
      "dateReceived": "2026-04-01"
    }
  ],
  "topApplicants": [
    {
      "name": "Nu Vasive, Incorporated",
      "count": 34
    },
    {
      "name": "Medtronic Sofamor Danek USA, Inc.",
      "count": 33
    },
    {
      "name": "Life Spine, Inc.",
      "count": 26
    },
    {
      "name": "Spineology, Inc.",
      "count": 22
    },
    {
      "name": "Globus Medical, Inc.",
      "count": 20
    }
  ],
  "topCompanies": [
    {
      "name": "Medtronic Sofamor Danek USA, Inc",
      "count": 37,
      "spellings": 2
    },
    {
      "name": "Nu Vasive, Incorporated",
      "count": 34,
      "spellings": 1
    },
    {
      "name": "Life Spine, Inc.",
      "count": 32,
      "spellings": 2
    },
    {
      "name": "Spineology, Inc.",
      "count": 22,
      "spellings": 1
    },
    {
      "name": "Alphatec Spine, Inc.",
      "count": 21,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Beijing Fule Science & Technology Development Co., Ltd.",
      "since": "2026-06-15",
      "kNumber": "K253151"
    },
    {
      "name": "Global Biomedica s.r.o.",
      "since": "2026-05-28",
      "kNumber": "K253894"
    },
    {
      "name": "Implanet",
      "since": "2026-02-26",
      "kNumber": "K254017"
    },
    {
      "name": "Xenix Medical",
      "since": "2026-02-23",
      "kNumber": "K253583"
    },
    {
      "name": "Cg Medtech Co., Ltd.",
      "since": "2025-10-28",
      "kNumber": "K252351"
    },
    {
      "name": "Mobarn Medical Devices, LLC",
      "since": "2025-09-18",
      "kNumber": "K251479"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 44,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 66,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 52,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 47,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 46,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 43,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 48,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 38,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 154,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 64,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 56,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 33,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 30,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 30,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 43,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 52,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 70,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 80,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 60,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 57,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 78,
        "expectedLow": 0,
        "expectedHigh": 119.49049928935273,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 63,
        "expectedLow": 25.206937531538262,
        "expectedHigh": 81.22676788627915,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 89,
        "expectedLow": 29.816357059903254,
        "expectedHigh": 95.67673228163682,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 84,
        "expectedLow": 31.659565445471507,
        "expectedHigh": 113.67910656766134,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 54,
        "expectedLow": 32.171903374105284,
        "expectedHigh": 110.36751785770502,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 82,
        "expectedLow": 32.708263958135944,
        "expectedHigh": 104.41345202315034,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 57,
        "expectedLow": 62.90480904357422,
        "expectedHigh": 165.6422813588829,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 60,
        "expectedLow": 34.43343175757049,
        "expectedHigh": 112.59303716492029,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 65,
        "expectedLow": 33.5450146400871,
        "expectedHigh": 113.28001161379999,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 59,
        "expectedLow": 29.810952745417797,
        "expectedHigh": 111.17360084613007,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 41,
        "expectedLow": 22.19441263093275,
        "expectedHigh": 98.24041987632388,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 63,
        "expectedLow": 14.513142103913413,
        "expectedHigh": 106.01664939948812,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 50,
        "expectedLow": 18.346788786219832,
        "expectedHigh": 123.66491431279067,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 54,
        "expectedLow": 8.419827283474797,
        "expectedHigh": 100.86344722712904,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 87,
        "expectedLow": 9.84088891912596,
        "expectedHigh": 110.22811677710729,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "MAX (Intervertebral Fusion Device With Bone Graft, Lumbar) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II, Class III) (Z-0892-2026, Z-0895-2026, Z-1038-2026, Z-1039-2026, Z-0580-2026). 6 first-time filers in the last 12 months, including Beijing Fule Science & Technology Development Co., Ltd. and Global Biomedica s.r.o (K253151, K253894, K254017, K253583, K252351). The code is crowded, scoring 100 of 100 — 254 companies hold a clearance here and 22 arrived in the last 12 months (MAX:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II, Class III)",
        "recordIds": [
          "Z-0892-2026",
          "Z-0895-2026",
          "Z-1038-2026",
          "Z-1039-2026",
          "Z-0580-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "6 first-time filers in the last 12 months, including Beijing Fule Science & Technology Development Co., Ltd. and Global Biomedica s.r.o.",
        "recordIds": [
          "K253151",
          "K253894",
          "K254017",
          "K253583",
          "K252351"
        ],
        "severity": 46
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 100 of 100 — 254 companies hold a clearance here and 22 arrived in the last 12 months",
        "recordIds": [
          "MAX: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%3AMAX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMAX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMAX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMAX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMAX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMAX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMAX"
    }
  ],
  "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"
}