{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 49
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Materialise Knee Guides",
        "Materialise Knee Guide System",
        "Materialise TKA Guide Planner",
        "BKS Total PSI",
        "Materialise SurgiCase Knee Module",
        "Materialise TKA Guides",
        "Signature Guides",
        "Lima Personalized Surgical Instruments",
        "Materialise TKA Guides and Models",
        "Materialise SurgiCase Knee Planner",
        "Zimmer Patient Specific Instruments Planner",
        "Zimmer Patient Specific Instruments",
        "Materialise Knee Planner",
        "Zimmer Biomet Patient Specific Instruments",
        "Signature Planner",
        "Materialise Knee Platform",
        "Materialise TKA Guide System",
        "SurgiCase Knee Planner"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3005718816",
        "fei_number": "3005718816",
        "status_code": "1",
        "initial_importer_flag": "Y",
        "reg_expiry_date_year": "2026",
        "name": "Materialise USA, LLC.",
        "address_line_1": "44650 Helm Court",
        "address_line_2": "",
        "city": "Plymouth",
        "state_code": "MI",
        "iso_country_code": "US",
        "zip_code": "48170",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "MATERIALISE N.V.",
          "owner_operator_number": "9029485",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Technologielaan 15",
            "address_2": "--",
            "city": "Leuven",
            "state_code": "BE-NOTA",
            "state_province": "",
            "iso_country_code": "BE",
            "postal_code": "3001"
          }
        }
      },
      "pma_number": "",
      "k_number": "K251554",
      "products": [
        {
          "product_code": "OIY",
          "created_date": "2025-09-25",
          "owner_operator_number": "9029485",
          "exempt": "",
          "openfda": {
            "device_name": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3560",
            "device_class": "2"
          }
        },
        {
          "product_code": "OOG",
          "created_date": "2025-09-25",
          "owner_operator_number": "9029485",
          "exempt": "",
          "openfda": {
            "device_name": "Knee Arthroplasty Implantation System",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3560",
            "device_class": "2"
          }
        },
        {
          "product_code": "MBH",
          "created_date": "2025-09-25",
          "owner_operator_number": "9029485",
          "exempt": "",
          "openfda": {
            "device_name": "Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3565",
            "device_class": "2"
          }
        },
        {
          "product_code": "JWH",
          "created_date": "2025-09-25",
          "owner_operator_number": "9029485",
          "exempt": "",
          "openfda": {
            "device_name": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3560",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}