FDA.reportPublic FDA data

Initia Total Hip System

Primary DI
04580810067548
Brand
Initia Total Hip System
Company
KYOCERA MEDICAL CORPORATION
Model
TJ34588-2
Device description
"""VERSION GUIDE SUPINE RIGHT"""
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
04547898736384PreviousGS10
04580810067548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547898736384045478987363844547898736384
04580810067548045808100675484580810067548

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
04580810067531Initia Total Hip SystemTJ34588-12026-02-27
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
Primary DIBrandCompanyProduct codePublished
00190776404192MillenniumAvalign Technologies, Inc.LXH2026-07-24
00810135961271ToejackNVision Biomedical Technologies, Inc.LXH2026-07-24
00840314263261gSourceGSOURCE LLCLXH2026-07-24
00840314263278gSourceGSOURCE LLCLXH2026-07-24
00840314263285gSourceGSOURCE LLCLXH2026-07-24
00840314263353gSourceGSOURCE LLCLXH2026-07-24
00840314263421gSourceGSOURCE LLCLXH2026-07-24
00840314263704gSourceGSOURCE LLCLXH2026-07-24
00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLCLXH2026-07-24
07640221373694SCALASpineArt SALXH2026-07-24
07640221373700SCALASpineArt SALXH2026-07-24
10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071040Surgical DirectSurgical Direct, Inc.LXH2026-07-24
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534930Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
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00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21