FDA.report

Initia Total Hip System

Primary DI
04580810068903
Brand
Initia Total Hip System
Company
KYOCERA MEDICAL CORPORATION
Model
TJ41394-11
Device description
"MX-HO LINER TRIAL 28-46 Type: Elevated, HO Inner Diameter: 28mm Outer Diameter: 46mm"
Published
2026-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04547898736483PreviousGS10
04580810068903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04547898736483045478987364834547898736483
04580810068903045808100689034580810068903

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
909-557-2360kmti.info@kyocera.com

Regulatory Flags

DUNS number
691363290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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
04580810067531Initia Total Hip SystemTJ34588-12026-02-27
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10885862660633N/AExactech, Inc.LPH2026-03-19
04580810066831Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810066909Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067784Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067807Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067821Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067845Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067869Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068163Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068170Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068187Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068194Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068385Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068422Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068620Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068668Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068699Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068705Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068712Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068729Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068736Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068743Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068750Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068767Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068774Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068781Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068798Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068804Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068811Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068828Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27