Initia Total Hip System

GUDID 04580810058546

"STDHO LINER 40-56/58 Size:40-56/58 Type:Flat, HO 40mm I.D. 56/58mm O.D."

KYOCERA MEDICAL CORPORATION

Metal-on-polyethylene total hip prosthesis
Primary Device ID04580810058546
NIH Device Record Key04909185-5090-4e22-b197-810d145c768e
Commercial Distribution StatusIn Commercial Distribution
Brand NameInitia Total Hip System
Version Model NumberGMH02-200185
Company DUNS691363290
Company NameKYOCERA MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104547898307409 [Previous]
GS104580810058546 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-27
Device Publish Date2026-02-19

On-Brand Devices [Initia Total Hip System]

04580810059116INITIA STEM HO #11 "Size: #11 Stem: High offset Taper: 12/14 Stem length: 119mm Neck length: 40
04580810059109INITIA STEM HO #10 "Size: #10 Stem: High offset Taper: 12/14 Stem length: 117mm Neck length: 40
04580810059093INITIA STEM HO #9 "Size: #9 Stem: High offset Taper: 12/14 Stem length: 115mm Neck length: 39mm
04580810059079INITIA STEM HO #7 "Size: #7 Stem: High offset Taper: 12/14 Stem length: 111mm Neck length: 40mm
04580810059062INITIA STEM HO #6.5 "Size: #6.5 Stem: High offset Taper: 12/14 Stem length: 109mm Neck length: 3
04580810059055INITIA STEM HO #6 "Size: #6 Stem: High offset Taper: 12/14 Stem length: 107mm Neck length: 39mm
04580810059017INITIA STEM HO #4 "Size: #4 Stem: High offset Taper: 12/14 Stem length: 102mm Neck length: 37mm
04580810058928INITIA STEM STD #11 "Size: #11 Stem: Standard offset Taper: 12/14 Stem length: 119mm Neck length
04580810058874INITIA STEM STD #6.5 "Size: #6.5 Stem: Standard offset Taper: 12/14 Stem length: 109mm Neck leng
04580810058294STD LINER 36-60/64 "Size:36-60/62/64 Type:Flat 36mm I.D. 60/62/64mm O.D."
04580810058263STD LINER 36-50 "Size:36-50 Type:Flat 36mm I.D. 50mm O.D."
04580810056429INITIA SHELL 56-3H "Size: φ56MM O.D. Type: 3 HOLE"
04580810056412INITIA SHELL 54-3H "Size: φ54MM O.D. Type: 3 HOLE"
04580810056405INITIA SHELL 52-3H "Size: φ52MM O.D. Type: 3 HOLE"
04580810056252INITIA SHELL 58-7H "Size: φ58MM O.D. Type: 7 HOLE"
04580810056221INITIA SHELL 52-7H "Size: φ52MM O.D. Type: 7 HOLE"
04580810059413"METAL HEAD 44 +10.5 Size: φ44MM O.D. Offset: +10.5mm Taper: 12/14"
04580810059406"METAL HEAD 44 +7 Size: φ44MM O.D. Offset: +7mm Taper: 12/14"
04580810059390"METAL HEAD 44 +3.5 Size: φ44MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059383"METAL HEAD 44 +0 Size: φ44MM O.D. Offset: +0mm Taper: 12/14"
04580810059376"METAL HEAD 44 -3.5 Size: φ44MM O.D. Offset: -3.5mm Taper: 12/14"
04580810059369"METAL HEAD 40 +10.5 Size: φ40MM O.D. Offset: +10.5mm Taper: 12/14"
04580810059352"METAL HEAD 40 +7 Size: φ40MM O.D. Offset: +7mm Taper: 12/14"
04580810059345"METAL HEAD 40 +3.5 Size: φ40MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059338"METAL HEAD 40 +0 Size: φ40MM O.D. Offset: +0mm Taper: 12/14"
04580810059321"METAL HEAD 40 -3.5 Size: φ40MM O.D. Offset: -3.5mm Taper: 12/14"
04580810059314"METAL HEAD 36 +10.5 Size: φ36MM O.D. Offset: +10.5mm Taper: 12/14"
04580810059307"METAL HEAD 36 +9 Size: φ36MM O.D. Offset: +9mm Taper: 12/14"
04580810059291"METAL HEAD 36 +7 Size: φ36MM O.D. Offset: +7mm Taper: 12/14"
04580810059284"METAL HEAD 36 +3.5 Size: φ36MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059277"METAL HEAD 36 +0 Size: φ36MM O.D. Offset: +0mm Taper: 12/14"
04580810059260"METAL HEAD 36 -3.5 Size: φ36MM O.D. Offset: -3.5mm Taper: 12/14"
04580810059253"METAL HEAD 32 +7 Size: φ32MM O.D. Offset: +7mm Taper: 12/14"
04580810059246"METAL HEAD 32 +3.5 Size: φ32MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059239"METAL HEAD 32 +0 Size: φ32MM O.D. Offset: +0mm Taper: 12/14"
04580810059222"METAL HEAD 32 -3.5 Size: φ32MM O.D. Offset: -3.5mm Taper: 12/14"
04580810059215"METAL HEAD 28 +7 Size: φ28MM O.D. Offset: +7mm Taper: 12/14"
04580810059208"METAL HEAD 28 +5 Size: φ28MM O.D. Offset: +5mm Taper: 12/14"
04580810059192"METAL HEAD 28 +3.5 Size: φ28MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059185"METAL HEAD 28 +0 Size: φ28MM O.D. Offset: +0mm Taper: 12/14"
04580810059178"METAL HEAD 28 -3.5 Size: φ28MM O.D. Offset: -3.5mm Taper: 12/14"
04580810059161"METAL HEAD 26 +3.5 Size: φ26MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059154"METAL HEAD 26 +0 Size: φ26MM O.D. Offset: +0mm Taper: 12/14"
04580810059147"METAL HEAD 26 -3.5 Size: φ26MM O.D. Offset: -3.5mm Taper: 12/14"
04580810059130"METAL HEAD 22 +3.5 Size: φ22MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059123"METAL HEAD 22 +0 Size: φ22MM O.D. Offset: +0mm Taper: 12/14"
04580810058812"INITIA STEM STD #3.5 Size: #3.5 Stem: Standard offset Taper: 12/14 Stem length: 99mm Neck lengt
04580810058805"INITIA STEM STD #3 Size: #3 Stem: Standard offset Taper: 12/14 Stem length: 99mm Neck length: 3
04580810058799"INITIA STEM STD #2.5 Size: #2.5 Stem: Standard offset Taper: 12/14 Stem length: 97mm Neck lengt
04580810058782"INITIA STEM STD #2 Size: #2 Stem: Standard offset Taper: 12/14 Stem length: 97mm Neck length: 3

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