FDA.report

Initia Total Hip System

Primary DI
04547898307751
Brand
Initia Total Hip System
Company
KYOCERA CORPORATION
Model
GMH02-200123
Catalog number
GMH02-200123
Device description
MXHO LINER 28-66/70
Published
2017-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

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
04547898307751PrimaryGS10

GMDN Terms

TermDefinition
Metal-on-polyethylene total hip prosthesisA sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
694697025
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04547898777561Initia Total Hip SystemTJ51146-1TJ51146-12023-05-24
04547898777578Initia Total Hip SystemTJ51146-2TJ51146-22023-05-24
04547898777585Initia Total Hip SystemTJ51146-3TJ51146-32023-05-24
04547898438974Initia Total Hip SystemTJ51147TJ511472022-12-06
04547898439025Initia Total Hip SystemTJ51146-1TJ51146-12022-12-06
04547898439032Initia Total Hip SystemTJ51146-2TJ51146-22022-12-06
04547898439049Initia Total Hip SystemTJ51146-3TJ51146-32022-12-06
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
04547898432514Initia Total Hip SystemTJ39643-1TJ39643-12021-11-30
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
04547898304712Initia Total Hip SystemGMH02-500011GMH02-5000112017-02-21
04547898304729Initia Total Hip SystemGMH02-500012GMH02-5000122017-02-21
04547898304736Initia Total Hip SystemGMH02-500013GMH02-5000132017-02-21
04547898304743Initia Total Hip SystemGMH02-500014GMH02-5000142017-02-21

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