{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QKW",
      "openfda": {
        "k_number": [
          "DEN220012"
        ],
        "registration_number": [
          "3000931034",
          "3003902387",
          "3002807295",
          "3010178296",
          "3008388276"
        ],
        "fei_number": [
          "3000931034",
          "3003902387",
          "3002807295",
          "3003110073",
          "3008388276"
        ]
      },
      "review_panel": "OR",
      "medical_specialty": "OR",
      "device_name": "Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Orthopedic",
      "device_class": "2",
      "definition": "A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty.",
      "regulation_number": "888.3695",
      "implant_flag": "Y",
      "submission_type_id": "1"
    }
  ]
}