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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 2 of 12
DeviceModel / ReferenceRegistriesClassStatus
Initia Total Hip System TJ39416
FDA UDI
Class IIActive
Initia Total Hip System TJ39652-1
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100050
FDA UDI
Class IIActive
Initia Total Hip System TJ33124
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200193
FDA UDI
Class IIActive
Initia Total Hip System TJ41391-43
FDA UDI
Class IIActive
Initia Total Hip System TJ41391-20
FDA UDI
Class IIActive
Initia Total Hip System TJ40157
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200189
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200155
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100036
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200038
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500023
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100022
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200132
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200144
FDA UDI
Class IIActive
Initia Total Hip System TJ34589
FDA UDI
Class IActive
Initia Total Hip System GMH02-200005
FDA UDI
Class IIActive
Initia Total Hip System TJ41391-31
FDA UDI
Class IIActive
Initia Total Hip System TJ41392-44
FDA UDI
Class IIActive
Initia Total Hip System TJ41391-16
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200159
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100007
FDA UDI
Class IIActive
Initia Total Hip System TJ34603-1
FDA UDI
Class IActive
Initia Total Hip System TJ33442-19
FDA UDI
Class IIActive
Initia Total Hip System TJ41394-19
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200136
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200098
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200175
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200106
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100039
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100040
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500030
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500025
FDA UDI
Class IIActive
Initia Total Hip System GMH03-400015
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100024
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200079
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500022
FDA UDI
Class IIActive
Initia Total Hip System GMH06-900014
FDA UDI
Class IIActive
Initia Total Hip System TJ34565
FDA UDI
Class IActive
Initia Total Hip System GMH02-100008
FDA UDI
Class IIActive
Initia Total Hip System 1183-6000-01
FDA UDI
Class IIActive
Initia Total Hip System TJ41393-43
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100012
FDA UDI
Class IIActive
Initia Total Hip System TJ39654-1
FDA UDI
Class IIActive
Initia Total Hip System TJ41392-38
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500040
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200153
FDA UDI
Class IIActive
Bioceram Azul Head GMH04-400063
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500016
FDA UDI
Class IIActive

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