FDA.reportPublic FDA data

Initia Total Hip System

Primary DI
04580810067531
Brand
Initia Total Hip System
Company
KYOCERA MEDICAL CORPORATION
Model
TJ34588-1
Device description
"""VERSION GUIDE SUPINE LEFT"""
Published
2026-02-27
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547898736377PreviousGS10
04580810067531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547898736377045478987363774547898736377
04580810067531045808100675314580810067531

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
691363290
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580810059420BIOCERAM AZUL HEADGMH04-400051GMH04-4000582026-02-27
04580810059437BIOCERAM AZUL HEADGMH04-400052GMH04-4000582026-02-27
04580810059444BIOCERAM AZUL HEADGMH04-400053GMH04-4000582026-02-27
04580810059451BIOCERAM AZUL HEADGMH04-400054GMH04-4000582026-02-27
04580810059499BIOCERAM AZUL HEADGMH04-400060GMH04-4000582026-02-27
04580810066831Initia Total Hip System1183-6006-012026-02-27
04580810066909Initia Total Hip System21057-00-00002026-02-27
04580810067029Initia Total Hip SystemBTJ449492026-02-27
04580810067524Initia Total Hip SystemTJ345652026-02-27
04580810067548Initia Total Hip SystemTJ34588-22026-02-27
04580810067784Initia Total Hip SystemTJ39639-12026-02-27
04580810067807Initia Total Hip SystemTJ39641-12026-02-27
04580810067821Initia Total Hip SystemTJ39643-12026-02-27
04580810067845Initia Total Hip SystemTJ39645-12026-02-27
04580810067869Initia Total Hip SystemTJ39647-12026-02-27
04580810068132Initia Total Hip SystemTJ403972026-02-27
04580810068163Initia Total Hip SystemTJ408212026-02-27
04580810068170Initia Total Hip SystemTJ408222026-02-27
04580810068187Initia Total Hip SystemTJ408232026-02-27
04580810068194Initia Total Hip SystemTJ408242026-02-27

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Primary DI, Brand, Company table
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