{
  "code": "LZO",
  "deviceName": "Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented",
  "deviceClass": "II",
  "regulationNumber": "888.3353",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 532,
    "last12Months": 7
  },
  "adverseEvents": {
    "total": 7961,
    "last12Months": 1888
  },
  "reviewDays": {
    "median": 94,
    "sampleSize": 532
  },
  "recalls": {
    "total": 177,
    "recent": [
      {
        "resNumber": "Z-0151-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Biopro, Inc.",
        "firmAsPublished": "BioPro, Inc.",
        "reason": "Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.",
        "initiated": "2025-09-09"
      },
      {
        "resNumber": "Z-1645-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.",
        "initiated": "2025-03-24"
      },
      {
        "resNumber": "Z-1646-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.",
        "initiated": "2025-03-24"
      },
      {
        "resNumber": "Z-1647-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.",
        "initiated": "2025-03-24"
      },
      {
        "resNumber": "Z-1648-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.",
        "initiated": "2025-03-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261009",
      "deviceName": "MobileLink Acetabular Cup System – 40mm ID Inserts (various)",
      "applicant": "Waldemar Link GmbH & Co. KG",
      "company": "Waldemar Link GmbH & Co. KG",
      "decisionDate": "2026-07-06",
      "dateReceived": "2026-03-26"
    },
    {
      "kNumber": "K260831",
      "deviceName": "Z1 Hip System",
      "applicant": "Zimmer, Inc.",
      "company": "Zimmer, Inc.",
      "decisionDate": "2026-06-16",
      "dateReceived": "2026-03-13"
    },
    {
      "kNumber": "K260182",
      "deviceName": "Avenir® Müller Stem; Avenir Complete™ Hip System",
      "applicant": "Zimmer, Inc.",
      "company": "Zimmer, Inc.",
      "decisionDate": "2026-04-27",
      "dateReceived": "2026-01-21"
    },
    {
      "kNumber": "K260037",
      "deviceName": "implantcast Packaging System Update",
      "applicant": "Implantcast GmbH",
      "company": "IMPLANTCAST GMBH",
      "decisionDate": "2026-03-30",
      "dateReceived": "2026-01-06"
    },
    {
      "kNumber": "K252401",
      "deviceName": "implaFit® short stems",
      "applicant": "Implantcast GmbH",
      "company": "IMPLANTCAST GMBH",
      "decisionDate": "2026-03-12",
      "dateReceived": "2025-07-31"
    },
    {
      "kNumber": "K253171",
      "deviceName": "Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)",
      "applicant": "Maxx Orthopedics, Inc.",
      "company": "Maxx Orthopedics, Inc.",
      "decisionDate": "2026-01-15",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K250450",
      "deviceName": "Coated hip implants",
      "applicant": "Medacta International S.A.",
      "company": "Medacta International S.A.",
      "decisionDate": "2025-09-19",
      "dateReceived": "2025-02-18"
    },
    {
      "kNumber": "K243021",
      "deviceName": "Longboard Revision Hip Stem",
      "applicant": "Signature Orthopaedics Pty, Ltd.",
      "company": "Signature Orthopaedics Pty Limited",
      "decisionDate": "2025-08-07",
      "dateReceived": "2024-09-27"
    },
    {
      "kNumber": "K251906",
      "deviceName": "Z1 Hip System",
      "applicant": "Zimmer, Inc.",
      "company": "Zimmer, Inc.",
      "decisionDate": "2025-07-18",
      "dateReceived": "2025-06-20"
    },
    {
      "kNumber": "K251292",
      "deviceName": "RECLAIM Monobloc Revision Femoral Stem",
      "applicant": "Depuy Ireland UC",
      "company": "Depuy Ireland UC",
      "decisionDate": "2025-05-23",
      "dateReceived": "2025-04-25"
    }
  ],
  "topApplicants": [
    {
      "name": "Medacta International S.A.",
      "count": 27
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 24
    },
    {
      "name": "Howmedica Osteonics Corp.",
      "count": 23
    },
    {
      "name": "Zimmer, Inc.",
      "count": 23
    },
    {
      "name": "Biomet, Inc.",
      "count": 21
    }
  ],
  "topCompanies": [
    {
      "name": "Zimmer, Inc.",
      "count": 34,
      "spellings": 2
    },
    {
      "name": "Howmedica Osteonics Corp.",
      "count": 27,
      "spellings": 3
    },
    {
      "name": "Medacta International S.A.",
      "count": 27,
      "spellings": 1
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 24,
      "spellings": 1
    },
    {
      "name": "Biomet, Inc.",
      "count": 21,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 190,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 147,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 148,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 158,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 163,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 179,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 183,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 173,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 129,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 211,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 171,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 208,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 212,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 291,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 245,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 231,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 217,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 176,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 197,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 186,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 241,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 189,
        "expectedLow": 124.8466308356725,
        "expectedHigh": 263.65218054508995,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 137,
        "expectedLow": 106.47545681906453,
        "expectedHigh": 228.3011471431079,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 232,
        "expectedLow": 107.28937491737642,
        "expectedHigh": 248.0524230633299,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 387,
        "expectedLow": 124.89505457354441,
        "expectedHigh": 276.2123787715093,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 269,
        "expectedLow": 119.79308010876825,
        "expectedHigh": 362.7859123469882,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 304,
        "expectedLow": 130.6448731597715,
        "expectedHigh": 386.47985340184044,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 364,
        "expectedLow": 212.0163934007459,
        "expectedHigh": 641.5987226958848,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 255,
        "expectedLow": 146.35934411781153,
        "expectedHigh": 469.9607506227588,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 261,
        "expectedLow": 138.57777195085995,
        "expectedHigh": 475.4277649691425,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 295,
        "expectedLow": 130.90571908340723,
        "expectedHigh": 451.88759905576995,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 216,
        "expectedLow": 125.59946375060495,
        "expectedHigh": 401.637351661325,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 285,
        "expectedLow": 128.9753647974793,
        "expectedHigh": 425.0822486580979,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 200,
        "expectedLow": 152.37748300592648,
        "expectedHigh": 491.39233891265366,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 173,
        "expectedLow": 85.62977328532669,
        "expectedHigh": 396.04574784456787,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 261,
        "expectedLow": 69.49443255221468,
        "expectedHigh": 416.85226725726017,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented) has two findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0151-2026). The code is crowded, scoring 67 of 100 — 97 companies hold a clearance here and 7 arrived in the last 12 months (LZO:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0151-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 67 of 100 — 97 companies hold a clearance here and 7 arrived in the last 12 months",
        "recordIds": [
          "LZO: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%3ALZO"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALZO"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALZO"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALZO"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALZO"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALZO"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALZO"
    }
  ],
  "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": "2026-08-11T13:51:45.742Z"
}