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Kyocera 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
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
909-557-2360
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
690557624

Catalogue (577)

Page 5 of 12
DeviceModel / ReferenceRegistriesClassStatus
Initia Total Hip System TJ34625
FDA UDI
Class IActive
Initia Total Hip System GMH02-500031
FDA UDI
Class IIActive
Initia Total Hip System TJ21732
FDA UDI
Class IActive
Initia Total Hip System TJ51146-1
FDA UDI
Class IActive
Initia Total Hip System GMH03-400011
FDA UDI
Class IIActive
Initia Total Hip System GMH03-400007
FDA UDI
Class IIActive
Initia Total Hip System GMH03-400024
FDA UDI
Class IIActive
Initia Total Hip System GMH03-400016
FDA UDI
Class IIActive
Initia Total Hip System GMH06-900023
FDA UDI
Class IIActive
Initia Total Hip System TJ42890
FDA UDI
Class IActive
Initia Total Hip System GMH02-500041
FDA UDI
Class IIActive
Initia Total Hip System TJ41391-44
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200018
FDA UDI
Class IIActive
Initia Total Hip System TJ41391-25
FDA UDI
Class IIActive
Initia Total Hip System TJ41394-37
FDA UDI
Class IIActive
Initia Total Hip System TJ41394-16
FDA UDI
Class IIActive
Initia Total Hip System TJ41392-52
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200100
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200036
FDA UDI
Class IIActive
Initia Total Hip System TJ41394-25
FDA UDI
Class IIActive
Initia Total Hip System TJ34281
FDA UDI
Class IIActive
Initia Total Hip System TJ41391-30
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200037
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500037
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200071
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200093
FDA UDI
Class IIActive
Initia Total Hip System TJ36137-3
FDA UDI
Class IActive
Initia Total Hip System GMH02-200086
FDA UDI
Class IIActive
Initia Total Hip System TJ40160
FDA UDI
Class IIActive
Initia Total Hip System TJ40395
FDA UDI
Class IActive
Initia Total Hip System TJ51461
FDA UDI
Class IActive
Initia Total Hip System GMH02-200134
FDA UDI
Class IIActive
Initia Total Hip System TJ39955-1
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100042
FDA UDI
Class IIActive
Bioceram Azul Head GMH04-400074
FDA UDI
Class IIActive
Initia Total Hip System TJ34563
FDA UDI
Class IActive
Initia Total Hip System GMH02-200187
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200032
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500039
FDA UDI
Class IIActive
Initia Total Hip System TJ34564
FDA UDI
Class IActive
Initia Total Hip System GMH02-500026
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200025
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200087
FDA UDI
Class IIActive
Bioceram Azul Head GMH04-400058
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200053
FDA UDI
Class IIActive
Initia Total Hip System TJ40397
FDA UDI
Class IActive
Initia Total Hip System GMH06-900021
FDA UDI
Class IIActive
Initia Total Hip System GMH03-400026
FDA UDI
Class IIActive
Initia Total Hip System TJ41393-20
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100046
FDA UDI
Class IIActive

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