Kyocera Medical Technologies, Inc.

Kyocera Medical Technologies, Inc. specializes in orthopaedic devices, including general internal orthopaedic fixation system implantation kits, spinal implants like metallic and polymeric interbody fusion cages and non-bioabsorbable spinal bone screws, as well as knee prostheses. These include posterior-stabilized and cruciate-retaining total knee replacements, as well as unicondylar knee prostheses for partial knee replacement. The company focuses on hardware used for spinal stabilization, joint reconstruction, and fracture fixation.

Kyocera Medical Technologies, Inc. is headquartered in the United States, which means its devices are subject to U.S. regulatory requirements, including those administered by the FDA. Since the company’s products are listed in the FDA’s Unique Device Identification (UDI) database, they must comply with U.S. medical device regulations, which classify them as either Class I or Class II devices depending on their risk profile and intended use.

Kyocera Medical Technologies, Inc.’s devices are included in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency of medical devices marketed in the U.S., allowing healthcare providers, regulators, and patients to access critical information about the devices, such as their identification, specifications, and regulatory status. Listing in this database is mandatory for devices sold in the U.S.

Kyocera Medical Technologies, Inc.’s devices are classified under the FDA’s medical device classification system as either Class I or Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional premarket notification (510(k)) clearance due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as spinal implants or knee prostheses.

The FDA’s UDI database includes all medical devices marketed in the U.S., but the level of regulatory scrutiny varies by device class. Kyocera’s devices are listed because they fall under U.S. jurisdiction, but not all devices may require the same level of premarket review. For example, Class I devices typically only need general controls and may not require a 510(k) submission, while Class II devices do. The UDI listing itself is mandatory for all devices sold in the U.S., regardless of class, to ensure traceability and compliance.