{
  "code": "JDI",
  "deviceName": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented",
  "deviceClass": "II",
  "regulationNumber": "888.3350",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 564,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 5036,
    "last12Months": 1023
  },
  "reviewDays": {
    "median": 87,
    "sampleSize": 564
  },
  "recalls": {
    "total": 255,
    "recent": [
      {
        "resNumber": "Z-0153-2026",
        "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-2640-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Howmedica Osteonics Corp.",
        "firmAsPublished": "Howmedica Osteonics Corp.",
        "reason": "a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.",
        "initiated": "2025-08-28"
      },
      {
        "resNumber": "Z-2423-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Onkos Surgical, Inc.",
        "firmAsPublished": "Onkos Surgical, Inc.",
        "reason": "Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.",
        "initiated": "2025-07-11"
      },
      {
        "resNumber": "Z-2424-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Onkos Surgical, Inc.",
        "firmAsPublished": "Onkos Surgical, Inc.",
        "reason": "Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.",
        "initiated": "2025-07-11"
      },
      {
        "resNumber": "Z-2425-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Onkos Surgical, Inc.",
        "firmAsPublished": "Onkos Surgical, Inc.",
        "reason": "Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.",
        "initiated": "2025-07-11"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253434",
      "deviceName": "OSSTM Orthopedic Salvage System",
      "applicant": "Biomet, Inc.",
      "company": "Biomet, Inc.",
      "decisionDate": "2026-07-01",
      "dateReceived": "2025-10-01"
    },
    {
      "kNumber": "K252824",
      "deviceName": "Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head",
      "applicant": "Signature Orthopaedics Pty, Ltd.",
      "company": "Signature Orthopaedics Pty Limited",
      "decisionDate": "2026-03-12",
      "dateReceived": "2025-09-05"
    },
    {
      "kNumber": "K243571",
      "deviceName": "Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners",
      "applicant": "Zimmer Biomet",
      "company": "Zimmer Biomet, Inc.",
      "decisionDate": "2025-07-31",
      "dateReceived": "2024-11-18"
    },
    {
      "kNumber": "K240783",
      "deviceName": "Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems",
      "applicant": "Smith & Nephew, Inc.",
      "company": "Smith & Nephew, Inc.",
      "decisionDate": "2024-10-21",
      "dateReceived": "2024-03-21"
    },
    {
      "kNumber": "K241716",
      "deviceName": "Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component",
      "applicant": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics",
      "company": "Howmedica Osteonics Corp.",
      "decisionDate": "2024-08-02",
      "dateReceived": "2024-06-14"
    },
    {
      "kNumber": "K240418",
      "deviceName": "Stryker Orthopaedics Hip Systems Labeling Update",
      "applicant": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics",
      "company": "Howmedica Osteonics Corp.",
      "decisionDate": "2024-04-12",
      "dateReceived": "2024-02-13"
    },
    {
      "kNumber": "K233261",
      "deviceName": "Global Modular Replacement System",
      "applicant": "Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics",
      "company": "Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics",
      "decisionDate": "2023-12-08",
      "dateReceived": "2023-09-29"
    },
    {
      "kNumber": "K222056",
      "deviceName": "Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee",
      "applicant": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics",
      "company": "Howmedica Osteonics Corp.",
      "decisionDate": "2023-01-26",
      "dateReceived": "2022-07-12"
    },
    {
      "kNumber": "K220216",
      "deviceName": "C-Stem AMT LE Prosthesis",
      "applicant": "Depuy Ireland UC",
      "company": "Depuy Ireland UC",
      "decisionDate": "2022-07-22",
      "dateReceived": "2022-01-26"
    },
    {
      "kNumber": "K213701",
      "deviceName": "Exeter® X3® RimFit® Cup",
      "applicant": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics",
      "company": "Howmedica Osteonics Corp.",
      "decisionDate": "2022-02-01",
      "dateReceived": "2021-11-24"
    }
  ],
  "topApplicants": [
    {
      "name": "Biomet, Inc.",
      "count": 51
    },
    {
      "name": "Depuy, Inc.",
      "count": 45
    },
    {
      "name": "Howmedica Corp.",
      "count": 35
    },
    {
      "name": "Osteonics Corp.",
      "count": 29
    },
    {
      "name": "Zimmer, Inc.",
      "count": 27
    }
  ],
  "topCompanies": [
    {
      "name": "Biomet, Inc.",
      "count": 51,
      "spellings": 1
    },
    {
      "name": "Depuy, Inc.",
      "count": 45,
      "spellings": 1
    },
    {
      "name": "Howmedica Corp.",
      "count": 43,
      "spellings": 2
    },
    {
      "name": "Osteonics Corp.",
      "count": 29,
      "spellings": 1
    },
    {
      "name": "Zimmer, Inc.",
      "count": 27,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 111,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 123,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 129,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 123,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 131,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 141,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 140,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 126,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 92,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 116,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 120,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 123,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 156,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 239,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 166,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 154,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 162,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 179,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 148,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 110,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 148,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 114,
        "expectedLow": 66.0480539857777,
        "expectedHigh": 200.5253208386962,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 177,
        "expectedLow": 52.82267781028241,
        "expectedHigh": 169.426345899845,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 108,
        "expectedLow": 75.407418269655,
        "expectedHigh": 217.68140533002637,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 119,
        "expectedLow": 64.25484133886575,
        "expectedHigh": 215.72688171433646,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 118,
        "expectedLow": 53.533008187329784,
        "expectedHigh": 198.93634422244241,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 146,
        "expectedLow": 69.15407902572609,
        "expectedHigh": 186.1242778636114,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 168,
        "expectedLow": 122.94926179886305,
        "expectedHigh": 294.0679725856243,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 88,
        "expectedLow": 81.46398981815845,
        "expectedHigh": 215.6088479596857,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 162,
        "expectedLow": 56.7397337957521,
        "expectedHigh": 218.41553091222423,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 129,
        "expectedLow": 68.44067420107973,
        "expectedHigh": 218.1721958448605,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 128,
        "expectedLow": 56.421124941382956,
        "expectedHigh": 193.35899516366368,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 139,
        "expectedLow": 65.62093520313984,
        "expectedHigh": 214.26911517626368,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 138,
        "expectedLow": 74.99312407640585,
        "expectedHigh": 246.58249835721531,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 126,
        "expectedLow": 57.385858104604914,
        "expectedHigh": 206.005430570689,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 136,
        "expectedLow": 93.93712155816506,
        "expectedHigh": 187.74734330634712,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented) has two findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0153-2026, Z-2640-2025). The code is crowded, scoring 61 of 100 — 111 companies hold a clearance here and 2 arrived in the last 12 months (JDI:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0153-2026",
          "Z-2640-2025"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 61 of 100 — 111 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "JDI: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%3AJDI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJDI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJDI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJDI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJDI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJDI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJDI"
    }
  ],
  "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": "2026-08-11T13:51:45.716Z"
}