{
  "code": "JWH",
  "deviceName": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",
  "deviceClass": "II",
  "regulationNumber": "888.3560",
  "panel": "Orthopedic",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 913,
    "last12Months": 9
  },
  "adverseEvents": {
    "total": 28318,
    "last12Months": 5080
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 913
  },
  "recalls": {
    "total": 983,
    "recent": [
      {
        "resNumber": "Z-2883-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "United Orthopedic Corporation",
        "firmAsPublished": "United Orthopedic Corp.",
        "reason": "Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.",
        "initiated": "2026-05-20"
      },
      {
        "resNumber": "Z-2700-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Encore Medical, Lp",
        "firmAsPublished": "Encore Medical, LP",
        "reason": "Due to packaging discrepancy with incorrect product size mixed up.",
        "initiated": "2026-02-16"
      },
      {
        "resNumber": "Z-2701-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Encore Medical, Lp",
        "firmAsPublished": "Encore Medical, LP",
        "reason": "Due to packaging discrepancy with incorrect product size mixed up.",
        "initiated": "2026-02-16"
      },
      {
        "resNumber": "Z-1459-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Encore Medical, Lp",
        "firmAsPublished": "Encore Medical, LP",
        "reason": "Knee and Humeral socket implants contain incorrect labeling.",
        "initiated": "2026-01-15"
      },
      {
        "resNumber": "Z-1233-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Encore Medical, Lp",
        "firmAsPublished": "Encore Medical, LP",
        "reason": "942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a  packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.",
        "initiated": "2026-01-05"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261734",
      "deviceName": "Klassic Infection Spacer System",
      "applicant": "Total Joint Orthopedics, Inc.",
      "company": "Total Joint Orthopedics, Inc.",
      "decisionDate": "2026-07-23",
      "dateReceived": "2026-05-26"
    },
    {
      "kNumber": "K261458",
      "deviceName": "ATTUNE Total Knee System; ATTUNE Cementless Knee System",
      "applicant": "DePuy Ireland UC",
      "company": "Depuy Ireland UC",
      "decisionDate": "2026-06-25",
      "dateReceived": "2026-05-01"
    },
    {
      "kNumber": "K261032",
      "deviceName": "NovoKnee (SteriKnee)",
      "applicant": "NovoSource",
      "company": "Novosource, LLC",
      "decisionDate": "2026-04-27",
      "dateReceived": "2026-03-30"
    },
    {
      "kNumber": "K253793",
      "deviceName": "Materialise TKA Guide System",
      "applicant": "Materialise NV",
      "company": "Materialise Sdn Bhd",
      "decisionDate": "2026-01-06",
      "dateReceived": "2025-11-28"
    },
    {
      "kNumber": "K252974",
      "deviceName": "EMPOWR Knee",
      "applicant": "Encore Medical L.P.",
      "company": "Encore Medical, L.P. Dba Djo Surgical",
      "decisionDate": "2025-12-19",
      "dateReceived": "2025-09-17"
    },
    {
      "kNumber": "K253197",
      "deviceName": "ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors",
      "applicant": "Depuy Ireland UC",
      "company": "Depuy Ireland UC",
      "decisionDate": "2025-11-19",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K253314",
      "deviceName": "Freedom Infinia™ Total Knee System",
      "applicant": "Maxx Orthopedics, Inc.",
      "company": "Maxx Orthopedics, Inc.",
      "decisionDate": "2025-10-29",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K253144",
      "deviceName": "Freedom® Total Knee System – Titan PCK Components",
      "applicant": "Maxx Orthopedics, Inc.",
      "company": "Maxx Orthopedics, Inc.",
      "decisionDate": "2025-10-22",
      "dateReceived": "2025-09-25"
    },
    {
      "kNumber": "K252725",
      "deviceName": "Stem Extension Line (U2 Total Knee System—PSA Type)",
      "applicant": "United Orthopedic Corporation",
      "company": "United Orthopedic Corporation",
      "decisionDate": "2025-09-25",
      "dateReceived": "2025-08-28"
    },
    {
      "kNumber": "K251554",
      "deviceName": "Materialise TKA Guide System",
      "applicant": "Materialise NV",
      "company": "Materialise Sdn Bhd",
      "decisionDate": "2025-07-14",
      "dateReceived": "2025-05-21"
    }
  ],
  "topApplicants": [
    {
      "name": "Zimmer, Inc.",
      "count": 51
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 49
    },
    {
      "name": "Howmedica Corp.",
      "count": 47
    },
    {
      "name": "Biomet, Inc.",
      "count": 40
    },
    {
      "name": "Conformis, Inc.",
      "count": 40
    }
  ],
  "topCompanies": [
    {
      "name": "Zimmer, Inc.",
      "count": 51,
      "spellings": 1
    },
    {
      "name": "Smith & Nephew, Inc.",
      "count": 49,
      "spellings": 1
    },
    {
      "name": "Howmedica Corp.",
      "count": 47,
      "spellings": 1
    },
    {
      "name": "Biomet, Inc.",
      "count": 40,
      "spellings": 1
    },
    {
      "name": "Conformis, Inc.",
      "count": 40,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 667,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 714,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 858,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 755,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 761,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 788,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 611,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 686,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 585,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 648,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 732,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 808,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 901,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1059,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 973,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 885,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 999,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 928,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1030,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 811,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1054,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 846,
        "expectedLow": 633.6653757445105,
        "expectedHigh": 1101.2676543947277,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 789,
        "expectedLow": 588.3535095683071,
        "expectedHigh": 913.811768066182,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 671,
        "expectedLow": 695.9063454534546,
        "expectedHigh": 1013.0510463170061,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 713,
        "expectedLow": 630.3126582281593,
        "expectedHigh": 1024.998181812045,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 799,
        "expectedLow": 541.8066716968472,
        "expectedHigh": 948.0479176153432,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 844,
        "expectedLow": 596.6768441190885,
        "expectedHigh": 982.3594006774315,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 854,
        "expectedLow": 1013.471899274361,
        "expectedHigh": 1510.1511565693074,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 648,
        "expectedLow": 599.9214379236695,
        "expectedHigh": 1125.9419540238932,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 684,
        "expectedLow": 517.2583754805524,
        "expectedHigh": 1162.353110756264,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 646,
        "expectedLow": 438.14047455018175,
        "expectedHigh": 1138.497962868595,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 805,
        "expectedLow": 337.5634342420105,
        "expectedHigh": 1002.1961822260668,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 748,
        "expectedLow": 422.5440916191648,
        "expectedHigh": 1158.4132520072492,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 558,
        "expectedLow": 508.18836181540297,
        "expectedHigh": 1282.796623990085,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 513,
        "expectedLow": 305.73916616699756,
        "expectedHigh": 1039.96621248708,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 685,
        "expectedLow": 297.76030348735867,
        "expectedHigh": 1064.5688668936868,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2883-2026, Z-2700-2026, Z-2701-2026, Z-1459-2026, Z-1233-2026). The code is crowded, scoring 72 of 100 — 133 companies hold a clearance here and 9 arrived in the last 12 months (JWH:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2883-2026",
          "Z-2700-2026",
          "Z-2701-2026",
          "Z-1459-2026",
          "Z-1233-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 72 of 100 — 133 companies hold a clearance here and 9 arrived in the last 12 months",
        "recordIds": [
          "JWH: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%3AJWH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJWH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJWH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJWH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJWH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJWH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJWH"
    }
  ],
  "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": "2026-08-11T13:51:45.728Z"
}