{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-01",
    "results": {
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  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "public_device_record_key": "600397f1-874f-4412-96f4-80b2feff61e6",
      "has_serial_number": "false",
      "public_version_date": "2025-05-30",
      "sterilization": {
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        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "5",
      "labeler_duns_number": "129278169",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00880304117464",
          "type": "Primary",
          "issuing_agency": "GS1"
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      ],
      "is_single_use": "true",
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      "version_or_model_number": "RD102535",
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      "brand_name": "KENNEDY PATELLAR SYSTEM",
      "is_combination_product": "false",
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          "code": "HRY",
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        {
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          "openfda": {
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            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3560",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K921182",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
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      "customer_contacts": [
        {
          "phone": "+1(800)348-9500",
          "email": "customerservice@zimmerbiomet.com"
        }
      ],
      "catalog_number": "RD102535",
      "company_name": "Biomet Orthopedics, LLC",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "34199",
          "name": "Polyethylene patella prosthesis",
          "definition": "An implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without bone cement.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2015-10-24",
      "device_sizes": [
        {
          "type": "Device Size Text, specify",
          "text": "37 MM"
        }
      ]
    }
  ]
}