FDA.reportPublic FDA data

Initia Total Hip System

Primary DI
04547898439049
Brand
Initia Total Hip System
Company
KYOCERA CORPORATION
Model
TJ51146-3
Catalog number
TJ51146-3
Device description
3.5MM DRILL BIT 60
Published
2022-12-06
Public version status
Update
Distribution status
Not 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
04547898439049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547898439049045478984390494547898439049

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
Premarket 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141040892Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040908Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040915Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040953Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040977Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047532Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047549Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00840314270351gSourceGSOURCE LLCLXH2026-10-22
00840606175234PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606185820PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186506LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186513LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186575SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186612SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186643SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186674SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186704SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186735SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186810SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187091ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187121PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187640OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189934OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189941OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00190776436766MillenniumAvalign Technologies, Inc.LXH2026-10-21
07630699705240Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705257Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705264Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705271Surgical Manual InstrumentMedacta International SALXH2026-10-21
10840642132786Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-21