{
  "code": "OVD",
  "deviceName": "Intervertebral Fusion Device With Integrated Fixation, Lumbar",
  "deviceClass": "II",
  "regulationNumber": "888.3080",
  "panel": "Orthopedic",
  "definition": "Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 202,
    "last12Months": 7
  },
  "adverseEvents": {
    "total": 199,
    "last12Months": 36
  },
  "reviewDays": {
    "median": 112,
    "sampleSize": 202
  },
  "recalls": {
    "total": 36,
    "recent": [
      {
        "resNumber": "Z-2213-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Novapproach Spine, LLC",
        "firmAsPublished": "Novapproach Spine, LLC",
        "reason": "Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.",
        "initiated": "2026-04-23"
      },
      {
        "resNumber": "Z-0893-2026",
        "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-1488-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Stryker Spine",
        "firmAsPublished": "Stryker Spine",
        "reason": "Potential for the gold unlock button to separate from the inserter.",
        "initiated": "2025-02-28"
      },
      {
        "resNumber": "Z-1489-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Stryker Spine",
        "firmAsPublished": "Stryker Spine",
        "reason": "Potential for the gold unlock button to separate from the inserter.",
        "initiated": "2025-02-28"
      },
      {
        "resNumber": "Z-1490-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Stryker Spine",
        "firmAsPublished": "Stryker Spine",
        "reason": "Potential for the gold unlock button to separate from the inserter.",
        "initiated": "2025-02-28"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261353",
      "deviceName": "Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System",
      "applicant": "Kyocera Medical Technologies, Inc.",
      "company": "Kyocera Medical Technologies, Inc.",
      "decisionDate": "2026-07-15",
      "dateReceived": "2026-04-24"
    },
    {
      "kNumber": "K260810",
      "deviceName": "Anteralign LS coverplate",
      "applicant": "Tyber Medical, LLC",
      "company": "Tyber Medical",
      "decisionDate": "2026-06-10",
      "dateReceived": "2026-03-12"
    },
    {
      "kNumber": "K254202",
      "deviceName": "MectaLIF 3D Metal Anterior",
      "applicant": "Medacta International S.A.",
      "company": "Medacta International S.A.",
      "decisionDate": "2026-05-05",
      "dateReceived": "2025-12-29"
    },
    {
      "kNumber": "K253401",
      "deviceName": "SCRIPT™ Implant System",
      "applicant": "Globus Medical, Inc.",
      "company": "Globus Medical, Inc.",
      "decisionDate": "2026-04-29",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K253559",
      "deviceName": "Ventana™ A Anterior Lumbar Interbody System",
      "applicant": "Spinal Elements, Inc.",
      "company": "Spinal Elements",
      "decisionDate": "2026-02-25",
      "dateReceived": "2025-11-17"
    },
    {
      "kNumber": "K251829",
      "deviceName": "DeGen Medical Patient Specific Implant (PSI) System",
      "applicant": "Degen Medical",
      "company": "Degen Medical, Inc.",
      "decisionDate": "2025-12-08",
      "dateReceived": "2025-06-13"
    },
    {
      "kNumber": "K251575",
      "deviceName": "IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System",
      "applicant": "Alphatec Spine",
      "company": "Alphatec Spine, Inc.",
      "decisionDate": "2025-09-03",
      "dateReceived": "2025-05-22"
    },
    {
      "kNumber": "K250072",
      "deviceName": "CONDUIT™ SYNFIX™ Evolution Secured Spacer System",
      "applicant": "Avalign Technologies, Inc.",
      "company": "Avalign Technologies, Inc.",
      "decisionDate": "2025-07-10",
      "dateReceived": "2025-01-10"
    },
    {
      "kNumber": "K251644",
      "deviceName": "ProAM ALIF System",
      "applicant": "Pro Surgical, Inc.",
      "company": "Pro Surgical, Inc.",
      "decisionDate": "2025-06-24",
      "dateReceived": "2025-05-29"
    },
    {
      "kNumber": "K250845",
      "deviceName": "Curiteva Porous PEEK Standalone ALIF System",
      "applicant": "Curiteva, Inc.",
      "company": "Curiteva, Inc.",
      "decisionDate": "2025-06-18",
      "dateReceived": "2025-03-20"
    }
  ],
  "topApplicants": [
    {
      "name": "Globus Medical, Inc.",
      "count": 11
    },
    {
      "name": "Nu Vasive, Incorporated",
      "count": 10
    },
    {
      "name": "K2m, Inc.",
      "count": 6
    },
    {
      "name": "Medacta International S.A.",
      "count": 5
    },
    {
      "name": "Alphatec Spine, Inc.",
      "count": 4
    }
  ],
  "topCompanies": [
    {
      "name": "Globus Medical, Inc.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Nu Vasive, Incorporated",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "K2M, Inc.",
      "count": 7,
      "spellings": 2
    },
    {
      "name": "Alphatec Spine, Inc.",
      "count": 5,
      "spellings": 2
    },
    {
      "name": "Medacta International S.A.",
      "count": 5,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Tyber Medical",
      "since": "2026-06-10",
      "kNumber": "K260810"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 14.084123343174209,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 11.328312759760607,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 12.331189958358346,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 11.859811261917711,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 12.096432158975183,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 13.150736383600742,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 15.163438846464382,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 11.48411389217644,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 8.793298167005952,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 6,
        "expectedLow": 0.536132011800252,
        "expectedHigh": 10.059947991369,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 2,
        "expectedLow": 0.6756120413666739,
        "expectedHigh": 9.317089875714572,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 9.36897563815594,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 10.311519228976218,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 8.109193665999266,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 10.343830276615934,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar) has three findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II, Class III) (Z-2213-2026, Z-0893-2026). 1 first-time filer in the last 12 months, Tyber Medical (K260810). The code is crowded, scoring 73 of 100 — 87 companies hold a clearance here and 7 arrived in the last 12 months (OVD:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II, Class III)",
        "recordIds": [
          "Z-2213-2026",
          "Z-0893-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Tyber Medical",
        "recordIds": [
          "K260810"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 73 of 100 — 87 companies hold a clearance here and 7 arrived in the last 12 months",
        "recordIds": [
          "OVD: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%3AOVD"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AOVD"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AOVD"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AOVD"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AOVD"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AOVD"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AOVD"
    }
  ],
  "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": "2026-08-11T13:51:45.750Z"
}