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Sign in to claim this brandKyocera Corporation
US
Last updated May 27, 2026
What Kyocera Corporation makes
Kyocera Corporation manufactures total hip prostheses, including metal-on-polyethylene and ceramic-on-polyethylene designs, as well as reusable joint prosthesis implantation kits. Their portfolio is centered on the Initia Total Hip System, which covers various configurations for hip replacement surgeries.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Kyocera Corporation operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Kyocera Corporation manufacture?
Kyocera Corporation specializes in orthopedic devices, specifically total hip prostheses. Their portfolio includes metal-on-polyethylene and ceramic-on-polyethylene total hip systems, as well as reusable joint prosthesis implantation kits. These devices are designed for hip replacement surgeries and are part of their Initia Total Hip System lineup.
Where is Kyocera Corporation based?
Kyocera Corporation operates from the United States. While the company’s global presence may extend beyond this region, its primary headquarters and regulatory focus are in the US.
Which regulatory registries list Kyocera Corporation’s devices?
Kyocera Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability in the healthcare system.
How are Kyocera Corporation’s devices classified under FDA regulations?
Kyocera Corporation’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional regulations due to moderate risk. The classification depends on factors like the device’s intended use and potential health impact.
What is the primary focus of Kyocera Corporation’s medical device portfolio?
Kyocera Corporation’s medical device portfolio is centered around the Initia Total Hip System, which includes various configurations of metal-on-polyethylene and ceramic-on-polyethylene total hip prostheses. These systems are designed to provide durable and reliable solutions for hip replacement surgeries, addressing common joint-related conditions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- kyocera.com
- —
- —
- [email protected]
- Phone
- 909-557-2360
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 690557624
Catalogue (577)
Page 8 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Initia Total Hip System | TJ41394-8 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ41391-45 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ51146-3 | FDA UDI | Class I | Active |
| Initia Total Hip System | TJ34354-1 | FDA UDI | Class I | Active |
| Initia Total Hip System | GMH02-200085 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ36137-2 | FDA UDI | Class I | Active |
| Bioceram Azul Head | GMH04-400067 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200180 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ41394-12 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ41391-52 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ41391-26 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200088 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ51146-3 | FDA UDI | Class I | Unknown |
| Initia Total Hip System | TJ41392-31 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200111 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-100044 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200107 | FDA UDI | Class II | Active |
| Bioceram Azul Head | GMH04-400061 | FDA UDI | Class II | Active |
| Bioceram Azul Head | GMH04-400057 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200157 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-100053 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200008 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200125 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ35045 | FDA UDI | Class I | Active |
| Bioceram Azul Head | GMH04-400079 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ33442-29 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-100030 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200121 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-100041 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200171 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200039 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200127 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-500046 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ33442-11 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ41392-11 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-100049 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200069 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ34282 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ41391-42 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ41391-12 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH03-400025 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200131 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200194 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200033 | FDA UDI | Class II | Active |
| Initia Total Hip System | 1183-6009-01 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ33442-15 | FDA UDI | Class II | Active |
| Bioceram Azul Head | GMH04-400078 | FDA UDI | Class II | Active |
| Initia Total Hip System | TJ39957-1 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-200158 | FDA UDI | Class II | Active |
| Initia Total Hip System | GMH02-100006 | FDA UDI | Class II | Active |
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