FDA.reportPublic FDA data

Initia Total Hip System

Primary DI
04547898432514
Brand
Initia Total Hip System
Company
KYOCERA CORPORATION
Model
TJ39643-1
Catalog number
TJ39643-1
Device description
INITIA BROACH 3.5
Published
2021-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547898432514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547898432514045478984325144547898432514

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
909-557-2360kmti.info@kyocera.com

Regulatory Flags#

DUNS number
690557624
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547898491160BIOCERAM AZUL HEADGMH04-400051GMH04-4000512025-01-29
04547898491177BIOCERAM AZUL HEADGMH04-400052GMH04-4000522025-01-29
04547898491184BIOCERAM AZUL HEADGMH04-400053GMH04-4000532025-01-29
04547898491191BIOCERAM AZUL HEADGMH04-400054GMH04-4000542025-01-29
04547898491207BIOCERAM AZUL HEADGMH04-400060GMH04-4000602025-01-29
04547898777561Initia Total Hip SystemTJ51146-1TJ51146-12023-05-24
04547898777578Initia Total Hip SystemTJ51146-2TJ51146-22023-05-24
04547898777585Initia Total Hip SystemTJ51146-3TJ51146-32023-05-24
04547898439025Initia Total Hip SystemTJ51146-1TJ51146-12022-12-06
04547898439032Initia Total Hip SystemTJ51146-2TJ51146-22022-12-06
04547898439049Initia Total Hip SystemTJ51146-3TJ51146-32022-12-06
04547898438974Initia Total Hip SystemTJ51147TJ511472022-12-06
04547898440434Initia Total Hip SystemTJ51461TJ514612022-12-06
04547898438080Initia Total Hip SystemTJ42890TJ428902022-11-09
04547898438233Initia Total Hip SystemTJ51247TJ512472022-11-09
04547898432491Initia Total Hip SystemTJ39639-1TJ39639-12021-11-30
04547898432507Initia Total Hip SystemTJ39641-1TJ39641-12021-11-30
04547898432521Initia Total Hip SystemTJ39645-1TJ39645-12021-11-30
04547898432538Initia Total Hip SystemTJ39647-1TJ39647-12021-11-30
04547898433979Initia Total Hip System21057-00-000021057-00-00002021-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448890MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
00810068850079Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850086Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850093Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850109Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850116Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850123Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850130Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850147Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850154Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850185Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850192Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850208Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850215Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850222Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26