Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012119238

FEI Number

3012119238

Entity Name

KYOCERA Medical Corporation Shiga Yasu Plant

City/State/Country

Yasu-shi Shiga, JP

Establishment Address

800 Ichimiyake, Yasu-shi Shiga 520-2362, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KYOCERA Medical Corporation (Owner Number: 9097359)

Owner / Operator Contact Address

6 Takeda Tobadono-cho, Fushimi-ku, --, Kyoto, JP-NOTA 612-8450, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AFFINITY CP CENTRIFUGAL BLOOD PUMP DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2010-07-28
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4380	2010-07-28
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-01-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2017-01-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-12-17
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2010-02-18
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-01-17
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2011-05-24
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2011-05-24

Official Correspondent

Masato Atsumi

US Agent Details

Cheryl Hastings Business: Hastings Regulatory Consulting, LLC Email: Cheryl-Hastings@comcast.net Phone: (574) 5274220

Related Public Records

Same Entity

KYOCERA Medical Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012425419	KYOCERA Medical Corporation	Kyoto, JP
3006536454	KYOCERA Medical Corporation Shiga Higashiomi Plant	Higashiomi-shi Shiga, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K860442	Howmedica Corp.	PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259	1986-05-06
K973124	Sulzer Orthopedics, Inc.	APR POROUS HA HIP SYSTEM	1997-11-03
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012119238. Last updated year: 2026. Please use registration number 3012119238 when referencing this establishment in official correspondence.