← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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 6 of 12
DeviceModel / ReferenceRegistriesClassStatus
Initia Total Hip System GMH03-400004
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100011
FDA UDI
Class IIActive
Initia Total Hip System TJ40402
FDA UDI
Class IActive
Initia Total Hip System GMH02-200183
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500021
FDA UDI
Class IIActive
Initia Total Hip System TJ41394-20
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100047
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500032
FDA UDI
Class IIActive
Initia Total Hip System GMH06-900019
FDA UDI
Class IIActive
Initia Total Hip System TJ34617
FDA UDI
Class IActive
Initia Total Hip System TJ41394-32
FDA UDI
Class IIActive
Initia Total Hip System TJ39415
FDA UDI
Class IIActive
Initia Total Hip System GMH03-400014
FDA UDI
Class IIActive
Initia Total Hip System GMH03-400013
FDA UDI
Class IIActive
Initia Total Hip System TJ33442-35
FDA UDI
Class IIActive
Initia Total Hip System TJ39645-1
FDA UDI
Class IIActive
Initia Total Hip System TJ34562
FDA UDI
Class IActive
Initia Total Hip System GMH02-100048
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500014
FDA UDI
Class IIActive
Initia Total Hip System GMH02-500012
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200034
FDA UDI
Class IIActive
Initia Total Hip System TJ41392-45
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100018
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200024
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200058
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200161
FDA UDI
Class IIActive
Initia Total Hip System TJ41393-16
FDA UDI
Class IIActive
Initia Total Hip System TJ41393-49
FDA UDI
Class IIActive
Initia Total Hip System GMH02-100028
FDA UDI
Class IIActive
Initia Total Hip System TJ41391-8
FDA UDI
Class IIActive
Initia Total Hip System TJ41392-21
FDA UDI
Class IIActive
Initia Total Hip System TJ34604-1
FDA UDI
Class IActive
Initia Total Hip System GMH02-200110
FDA UDI
Class IIActive
Initia Total Hip System TJ34622
FDA UDI
Class IActive
Initia Total Hip System TJ41394-51
FDA UDI
Class IIActive
Bioceram Azul Head GMH04-400056
FDA UDI
Class IIActive
Initia Total Hip System TJ33673
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200044
FDA UDI
Class IIActive
Initia Total Hip System TJ51147
FDA UDI
Class IActive
Initia Total Hip System TJ34480
FDA UDI
Class IActive
Initia Total Hip System TJ41393-32
FDA UDI
Class IIActive
Initia Total Hip System TJ51247
FDA UDI
Class IActive
Initia Total Hip System TJ40823
FDA UDI
Class IIActive
Bioceram Azul Head GMH04-400065
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200019
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200054
FDA UDI
Class IIActive
Initia Total Hip System TJ20467-1
FDA UDI
Class IActive
Initia Total Hip System GMH02-200122
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200181
FDA UDI
Class IIActive
Initia Total Hip System GMH02-200152
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.